FDA Device Recall Z-1172-2024: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1172-2024.

Recall Res Number

Z-1172-2024

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-01-03

Date Posted

2024-02-21

Date Terminated

N/A

Product Code

LLZ

Event Number

93855

Product Quantity

Product Description Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

Reason for Recall The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.

Action Details On January 3, 2024, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. Fujifilm will offer to correct the formula that calculates the LV Mass (2D Bullet) in the Synapse database. Until the update is scheduled and completed, customers may continue to safely use the Pediatric Workflow modules listed in the notice as long as the LV Mass (2D Bullet) equation is not the main factor for a diagnosis. Customers should coordinate with the Fujifilm service engineer to schedule the correction of their device when contacted. Please contact Fujifilm's field action coordinator, Kotei Aoki, via phone at 765-246-2931 or email at kotei.aoki@fujifilm.com, if you have any further questions regarding this field action.

Distribution Pattern US domestic distribution nationwide. International distribution to Israel.

Code Information / Serial Numbers UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

Related Establishments / Registrations

ADVANTECH CORPORATION Registration: 1000314502 View Registration
MEDICREA INTERNATIONAL Registration: 1000432246 View Registration
FUJIFILM Healthcare Americas Corporation Registration: 1000513161 View Registration
BIOMET MICROFIXATION Registration: 1032347 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
MEDTRONIC XOMED, INC. Registration: 1045254 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
CDB CORPORATION Registration: 1054415 View Registration
REMINGTON MEDICAL, INC. Registration: 1056553 View Registration
KLS-Martin L.P. Registration: 1057946 View Registration
STORZ MEDICAL AMERICA, INC. Registration: 1061158 View Registration
ASPYRA, LLC. Registration: 1063008 View Registration
Konica Minolta Healthcare Americas, Inc Registration: 1064396 View Registration
FORESIGHT IMAGING, LLC Registration: 1064588 View Registration
SYNTERMED, INC. Registration: 1066019 View Registration
THINKING SYSTEMS CORP. Registration: 1066247 View Registration
RADIOLOGY INFORMATION SYSTEMS, INC. Registration: 1125622 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
Carestream Dental LLC Registration: 1226003 View Registration
OMNIlifeScience, Inc. Registration: 1226188 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
CORTECHS LABS, INC. Registration: 1226773 View Registration
Carestream Health, Inc Registration: 1317307 View Registration
MINXRAY, INC. Registration: 1418960 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1423253 View Registration
VOLK OPTICAL INC. Registration: 1528142 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
BRIT SYSTEMS Registration: 1647172 View Registration
Covidien Registration: 1717344 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
NOVARAD CORP. Registration: 1721964 View Registration
MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration
MEDICAL MODELING - A 3D SYSTEMS COMPANY Registration: 1724955 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
ZIMMER, INC. Registration: 1822565 View Registration
Skytron, LLC Registration: 1825014 View Registration
BIOMET, INC. Registration: 1825034 View Registration
Esaote North America, Inc Registration: 1826555 View Registration
SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration
Vonco Products, LLC Registration: 1834003 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1836549 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
KARL STORZ IMAGING, INC. Registration: 2027009 View Registration
BIOSEAL Registration: 2027062 View Registration
ALPHATEC SPINE, INC. Registration: 2027467 View Registration
OSTEOMED Registration: 2027754 View Registration
VISION CHIPS, INC. Registration: 2031081 View Registration
NUVASIVE, INC. Registration: 2031966 View Registration
GE PARALLEL DESIGN, INC. Registration: 2032350 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
Spartronics Watertown LLC Registration: 2133772 View Registration
CANON MEDICAL INFORMATICS, INC. Registration: 2134213 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration
ORTHOFIX US LLC Registration: 2183449 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2183553 View Registration
Merge Healthcare Incorporated Registration: 2183926 View Registration
STANDARD IMAGING, INC. Registration: 2184007 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
MEDLINK IMAGING, LLC. Registration: 2433615 View Registration
Siemens Medical Solutions USA, Inc. Registration: 2531814 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
EIGEN Registration: 2937707 View Registration
SCIMAGE, INC. Registration: 2952596 View Registration
TELEVERE SYSTEMS Registration: 2954358 View Registration
ERAD, INC. Registration: 2954766 View Registration
NDS SURGICAL IMAGING, LLC. Registration: 2954921 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
SOTA PRECISION OPTICS, INC. Registration: 3000190675 View Registration
Patterson Dental Canada Inc. Registration: 3000219976 View Registration
EIZO CORPORATION Registration: 3000237660 View Registration
Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
Durr Optronik GmbH & Co. KG Registration: 3001052305 View Registration
MEDIA LAB S.P.A. Registration: 3001106601 View Registration
AGFA N.V. Registration: 3001556265 View Registration
INTUITIVE SURGICAL, INC. Registration: 3001675293 View Registration
FUJIFILM CORPORATION Registration: 3001722928 View Registration
Arthrex GmbH Registration: 3002579136 View Registration
Siemens Healthineers Ltd. Registration: 3002619337 View Registration
J. MORITA MFG. CORP. Registration: 3002807636 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
DE GOTZEN S.R.L. Registration: 3002994636 View Registration
SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. Registration: 3003202425 View Registration
NICAL SPA Registration: 3003314115 View Registration
SEGAMI CORPORATION Registration: 3003370689 View Registration
BLUE SKY BIO, LLC Registration: 3003402534 View Registration
CCE CANADA COMMERCIAL EXCHANGE INC. Registration: 3003412859 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
MEDSTRAT Registration: 3003574171 View Registration
TRIGON AMERICA LLC Registration: 3003596442 View Registration
SMITH & NEPHEW INC. Registration: 3003604053 View Registration
MEDISO Ltd.. Registration: 3003757027 View Registration
Philips Medical Systems DMC GmbH Registration: 3003768251 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
KONICA MINOLTA, INC. Registration: 3003769120 View Registration
FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office Registration: 3003775006 View Registration
Cybermed Inc. Registration: 3003781339 View Registration
MEDIMATIC S.R.L. Registration: 3003807472 View Registration
AYCAN DIGITALSYSTEME GMBH Registration: 3003895711 View Registration
FH INDUSTRIE Registration: 3003898228 View Registration
MACKAY MANUFACTURING, INC. Registration: 3003935342 View Registration
MEDICAL STANDARD CO., LTD. Registration: 3003941243 View Registration
SOFTLINK INTERNATIONAL PVT. LTD. Registration: 3003989043 View Registration
INFINITT HEALTHCARE CO., LTD. Registration: 3003989064 View Registration
MedicalCommunications GmbH Registration: 3003995303 View Registration
MATERIALISE N.V. Registration: 3003998208 View Registration
GlobalMed Holdings, LLC Registration: 3004009431 View Registration
SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD. Registration: 3004016520 View Registration
FIRST SOURCE INC. Registration: 3004063527 View Registration
TruBridge, Inc. Registration: 3004120479 View Registration
DONSON MACHINE COMPANY Registration: 3004153896 View Registration
INDUSTRIAS MEDICAS SAMPEDRO S.A.S Registration: 3004187715 View Registration
Xoran Technologies, LLC Registration: 3004198450 View Registration
MIM SOFTWARE INC. Registration: 3004363352 View Registration
LG Electronics Nanjing New Technology Co., Ltd. Registration: 3004434200 View Registration
KONICA MINOLTA, INC. Registration: 3004485675 View Registration
GE Healthcare GmbH Registration: 3004497354 View Registration
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC Registration: 3004504920 View Registration
GE HEALTHCARE Registration: 3004526608 View Registration
MERIDIAN TECHNIQUE LTD Registration: 3004537781 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 3004555721 View Registration
VATECH CO., LTD. Registration: 3004706313 View Registration
EBM TECHNOLOGIES, INC. Registration: 3004722076 View Registration
MEDSYNAPTIC PRIVATE LTD. Registration: 3004730352 View Registration
CHISON Medical Technologies Co., Ltd. Registration: 3004753388 View Registration
3D INDUSTRIAL IMAGING CO., LTD. Registration: 3004755841 View Registration
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. Registration: 3004756607 View Registration
KASHMIR SURGICAL WORKS Registration: 3004765453 View Registration
EDDA TECHNOLOGY, INC. Registration: 3004857110 View Registration
DENTSPLY SIRONA INC Registration: 3004884150 View Registration
Apryse Software Corp. Registration: 3004915908 View Registration
INTELLIGENCE IN MEDICAL TECHNOLOGIES Registration: 3004951433 View Registration
COACTIV MEDICAL BUSINESS SOLUTIONS Registration: 3004957385 View Registration
Covidien llc Registration: 3004962788 View Registration
FUJIFILM Healthcare Americas Corporation Registration: 3004972322 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
INVIA, LLC Registration: 3004993756 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
MAZOR ROBOTICS LTD. Registration: 3005075696 View Registration
RIVERAIN TECHNOLOGIES Registration: 3005156333 View Registration
DRTECH Corporation Registration: 3005172103 View Registration
MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration
NEOLOGICA S.R.L. Registration: 3005202320 View Registration
AS SOFTWARE, LLC Registration: 3005207094 View Registration
Brainlab Ltd. Registration: 3005225421 View Registration
PALODEX GROUP OY Registration: 3005383085 View Registration
KONICA MINOLTA TECHNOPRODUCTS CO., LTD. Registration: 3005406110 View Registration
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD Registration: 3005450718 View Registration
HOLOGIC, INC. Registration: 3005496266 View Registration
PRISM CLINICAL IMAGING, INC. Registration: 3005517190 View Registration
TURNER MEDICAL INC. Registration: 3005706667 View Registration
Materialise USA, LLC. Registration: 3005718816 View Registration
Nobel Biocare c/o Medicim NV Registration: 3005739655 View Registration
CARESTREAM HEALTH, INC., GLOBAL R&D CENTER Registration: 3005778458 View Registration
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC Registration: 3005860720 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
ZIRKONZAHN SRL Registration: 3005904906 View Registration
NEOSOFT, LLC Registration: 3005914761 View Registration
ADVANCED IMAGE ENHANCEMENT, INC. Registration: 3005916315 View Registration
CANDELIS, INC. Registration: 3005919188 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama Registration: 3005930550 View Registration
3Shape A/S Registration: 3005940400 View Registration
CMR NAVISCAN CORPORATION Registration: 3005945241 View Registration
VIEWORKS CO., LTD. Registration: 3006013411 View Registration
NEXUS / CHILI GmbH Registration: 3006060685 View Registration
SICAT GMBH & CO. KG Registration: 3006098230 View Registration
JPI Healthcare Co., Ltd Registration: 3006115340 View Registration
ResolutionMD, Inc. Registration: 3006123366 View Registration
EOS imaging Registration: 3006165260 View Registration
IMAGE INFORMATION SYSTEMS EUROPE GmbH Registration: 3006165530 View Registration
Wenzel Spine Registration: 3006172536 View Registration
Spectrum Dynamics Medical Ltd. Registration: 3006209933 View Registration
Bard Access Systems, Inc. Registration: 3006260740 View Registration
Hologic, Inc. Registration: 3006330030 View Registration
OEHM UND REHBEIN GMBH Registration: 3006542593 View Registration
DRGEM CORPORATION Registration: 3006551157 View Registration
SHINA SYSTEMS LTD. Registration: 3006551230 View Registration
MEDCOM GMBH Registration: 3006579682 View Registration
CEFLA S.C. Registration: 3006610845 View Registration
INTER MEDICAL MEDIZINTECHNIK GMBH Registration: 3006611212 View Registration
ZIOSOFT, INC. Registration: 3006621332 View Registration
SYNCA MARKETING Registration: 3006697692 View Registration
NORDICNEUROLAB AS Registration: 3006738448 View Registration
Siemens Healthineers AG Varian Cancer Therapy (CTH) Registration: 3006894636 View Registration
Siemens Healthineers Ltd. Registration: 3006985147 View Registration
Arthrex California Technology, Incorporated Registration: 3006990600 View Registration
VOYAGER IMAGING Registration: 3007005340 View Registration
Three Palm Software Registration: 3007038409 View Registration
GE Healthcare Magyarorszag Kft. Registration: 3007120336 View Registration
DIO Corporation Registration: 3007126709 View Registration
Avnet Global Solution Center Registration: 3007137598 View Registration
Varian Medical Systems, Inc. Registration: 3007157255 View Registration
VENTRIPOINT DIAGNOSTICS LTD. Registration: 3007194257 View Registration
IMAGING BIOMETRICS, LLC Registration: 3007225492 View Registration
CIRCLE CARDIOVASCULAR IMAGING INC Registration: 3007301305 View Registration
HALIFAX BIOMEDICAL INC. Registration: 3007305589 View Registration
Hyland Software Canada ULC Registration: 3007339076 View Registration
Planet DDS Registration: 3007350723 View Registration
DENTSPLY Implants N.V. Registration: 3007362683 View Registration
MOSER-BAER AG Registration: 3007441485 View Registration
TRILLIUM TECHNOLOGY, INC Registration: 3007457520 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
OLEA MEDICAL Registration: 3007675959 View Registration
MIRADA MEDICAL LIMITED Registration: 3007697958 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
VIRTUAL RADIOLOGIC CORPORATION Registration: 3007795813 View Registration
CORETRONIC PROJECTION (KUNSHAN) CORPORATION Registration: 3007809729 View Registration
Broncus Medical Inc Registration: 3007867778 View Registration
Structure Medical, LLC. Registration: 3007993775 View Registration
Spectrum Dynamics Medical Inc. Registration: 3008007310 View Registration
StatRad, LLC Registration: 3008008144 View Registration
LUMEDX Registration: 3008012314 View Registration
BLUE ORTHO Registration: 3008027912 View Registration
MEDACTA INTERNATIONAL SA Registration: 3008110533 View Registration
ZMICRO, INC. Registration: 3008142630 View Registration
MILLENSYS Registration: 3008177920 View Registration
ANATOMAGE, INC. Registration: 3008272529 View Registration
HM PRODUCT SOLUTIONS, LTD. Registration: 3008355361 View Registration
CUATTRO IMAGING, LLC Registration: 3008364043 View Registration
Double Black Imaging Corporation Registration: 3008481104 View Registration
KOELIS Registration: 3008487708 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
Biobot Surgical Pte. Ltd. Registration: 3008548323 View Registration
Hyland Software, Inc. Registration: 3008596921 View Registration
Nobel Biocare Services AG Registration: 3008693672 View Registration
DICOM Grid (dba Ambra Health) Registration: 3008776294 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
EPSILON IMAGING, INC. Registration: 3008840981 View Registration
MEDVISO AB Registration: 3008962159 View Registration
RAYENCE CO., LTD. Registration: 3009048384 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
LUNIT INTERNATIONAL LIMITED Registration: 3009117933 View Registration
RadmediX, LLC Registration: 3009134655 View Registration
RADIALOGICA LLC Registration: 3009140718 View Registration
NUVASIVE, INC. Registration: 3009144915 View Registration
ORTHO2 Registration: 3009149931 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
MEDTECH SAS Registration: 3009185973 View Registration
VanDuzen, Inc. dba MedCAD Registration: 3009196021 View Registration
LBN MEDICAL A/S Registration: 3009196578 View Registration
Agfa HealthCare Registration: 3009238175 View Registration
Agfa HealthCare GmbH Registration: 3009238185 View Registration
CD Newco Canada Inc. Registration: 3009246966 View Registration
NSE-AUTOMATECH Registration: 3009293341 View Registration
DOSISOFT Registration: 3009302839 View Registration
PAXERAHEALTH CORP Registration: 3009341091 View Registration
imfoU CO., LTD Registration: 3009463023 View Registration
SWISSMEDA AG Registration: 3009489134 View Registration
Philips Healthcare (Suzhou) Co., Ltd. Registration: 3009529630 View Registration
DIGIRAY CORP Registration: 3009532935 View Registration
CurveBeam, LLC Registration: 3009543051 View Registration
Materialise Ukraine, Rep. office Registration: 3009555440 View Registration
Materialise Sdn Bhd Registration: 3009555447 View Registration
UC-CARE Registration: 3009598843 View Registration
Mach7 Technologies Canada Inc. Registration: 3009601121 View Registration
STERIPACK USA (LIMITED) LLC Registration: 3009656988 View Registration
iCRco Inc. Registration: 3009717300 View Registration
ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
SAMSUNG MEDISON CO., LTD. Registration: 3009758186 View Registration
CD Newco, LLC. Registration: 3009833070 View Registration
ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration
ORTHOSELECT Registration: 3010111497 View Registration
Koios Medical, Inc. Registration: 3010119782 View Registration
POLAREAN, INC. Registration: 3010132318 View Registration
EXINI DIAGNOSTICS AB Registration: 3010146120 View Registration
Synergy Health Allershausen GmbH Registration: 3010160527 View Registration
SURGICAL THEATER, INC. Registration: 3010197287 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
BAECHLER FEINTECH AG Registration: 3010287737 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
ORTHOGRID SYSTEMS, INC Registration: 3010342382 View Registration
DENTAL WINGS GMBH Registration: 3010377510 View Registration
RAY CO., LTD, Registration: 3010445368 View Registration
MARREK, INC. Registration: 3010533307 View Registration
MEVIS MEDICAL SOLUTIONS AG Registration: 3010601176 View Registration
HINACOM SOFTWARE AND TECHNOLOGY, LTD. Registration: 3010626822 View Registration
Philips Medical Systems Technologies Ltd Registration: 3010656400 View Registration
Philips India Limited Registration: 3010685285 View Registration
O.N. DIAGNOSTICS, LLC Registration: 3010687441 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
3shape inc Registration: 3010728558 View Registration
Intellijoint Surgical Inc. Registration: 3010822102 View Registration
Visual Medica Registration: 3010956703 View Registration
MEDECOM Registration: 3010966991 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
MEDQIA, LLC Registration: 3011114764 View Registration
Ewoosoft Co., Ltd Registration: 3011189058 View Registration
ISCHEMAVIEW, INC. Registration: 3011205675 View Registration
GP&P CO., LTD. Registration: 3011213614 View Registration
MedDream UAB Registration: 3011221136 View Registration
mediCAD HECTEC GMBH Registration: 3011221522 View Registration
THERENVA Registration: 3011240766 View Registration
SWEDEN & MARTINA INC Registration: 3011276344 View Registration
TELERAD TECH Registration: 3011307657 View Registration
CLEAR GUIDE MEDICAL Registration: 3011396687 View Registration
MetriTrack, Inc. Registration: 3011411309 View Registration
RAY AMERICA INC Registration: 3011471624 View Registration
ECHOPIXEL, INC. Registration: 3011501361 View Registration
EXOCAD GMBH Registration: 3011521456 View Registration
MTT GMBH Registration: 3011545155 View Registration
Brainreader Registration: 3011657336 View Registration
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Registration: 3011676026 View Registration
MINT MEDICAL GMBH Registration: 3011706018 View Registration
BLACKFORD ANALYSIS LTD Registration: 3011713193 View Registration
GLOBUS MEDICAL, INC. Registration: 3011713200 View Registration
Materialise Colombia S.A.S Registration: 3011724582 View Registration
DEMCON PRODUCTION B.V. Registration: 3011790297 View Registration
DENTSPLY IH BV Registration: 3011824442 View Registration
Focal Healthcare Inc. Registration: 3011853771 View Registration
Synaptive Medical Inc Registration: 3012075008 View Registration
KARL STORZ ENDOSCOPY CANADA LTD. Registration: 3012322232 View Registration
Novadaq Technologies ULC Registration: 3012345110 View Registration
International Medical Solutions Inc. Registration: 3012391689 View Registration
VISIBLE PATIENT LAB Registration: 3012448806 View Registration
Arthrex Japan G.K. (Shinjuku) Registration: 3012470322 View Registration
PIXMEO SARL Registration: 3012516536 View Registration
VISARIS D.O.O. Registration: 3012569470 View Registration
TAMUZ F.T.K. SOLUTIONS Registration: 3012911444 View Registration
OPTIMIZED ORTHO PTY LTD Registration: 3012916784 View Registration
Dymax, Corp. Registration: 3013041594 View Registration
iRay Group Registration: 3013186032 View Registration
Intuitive Surgical G.K. Registration: 3013283620 View Registration
ARTERYS INC. Registration: 3013306229 View Registration
Progressive Aligners Registration: 3013342228 View Registration
icometrix Registration: 3013427569 View Registration
Henry Schein One, LLC Registration: 3013464458 View Registration
QUANTIB BV Registration: 3013497030 View Registration
LG ELECTRONICS INC. Registration: 3013501671 View Registration
JAZZ IMAGING Registration: 3013503781 View Registration
HDX WILL CORP. Registration: 3013511605 View Registration
JOINTVUE, LLC Registration: 3013535906 View Registration
KICO KNEE INNOVATION COMPANY Registration: 3013552417 View Registration
ELUCID BIOIMAGING Registration: 3013660213 View Registration
RESOUNDANT, INC. Registration: 3013695852 View Registration
EXOCAD AMERICA, INC. Registration: 3013718526 View Registration
EBIT S.r.l. Registration: 3013839079 View Registration
DANELIS MEDICAL LIMITED Registration: 3013844297 View Registration
INTEWARE CO., LTD Registration: 3013912897 View Registration
Arthrex Singapore Pte Ltd. Registration: 3014004349 View Registration
IRM INC. Registration: 3014055202 View Registration
SYNTHETICMR AB Registration: 3014111222 View Registration
CEEVRA, INC. Registration: 3014132130 View Registration
Terarecon, Inc. Registration: 3014146081 View Registration
PERSPECTUM LTD. Registration: 3014232555 View Registration
Arthrex (Shanghai) Co., Ltd. Registration: 3014262693 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
Densitas Inc. Registration: 3014343888 View Registration
TRACKX TECHNOLOGY Inc. Registration: 3014391847 View Registration
Carestream Dental Technology Topco Limited Registration: 3014398772 View Registration
COMBINOSTICS Registration: 3014470527 View Registration
KLS MARTIN MANUFACTURING, LLC Registration: 3014483751 View Registration
BODY VISION MEDICAL LTD Registration: 3014491269 View Registration
ZED TECHNOLOGIES Registration: 3014498512 View Registration
VOMARK TECHNOLOGIES INC Registration: 3014639846 View Registration
Viz.ai Israel Ltd Registration: 3014665798 View Registration
VIZ.AI, INC. Registration: 3014678441 View Registration
SONAVEX, INC. Registration: 3014680735 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
ImmersiveTouch, Inc. Registration: 3014833795 View Registration
CONVERGENT IMAGING SOLUTIONS Registration: 3014954414 View Registration
NDS Surgical Imaging, LLC Registration: 3014991167 View Registration
ASCEND CARDIOVASCULAR LLC Registration: 3015168097 View Registration
CORELINE SOFT CO., LTD. Registration: 3015169361 View Registration
3DIEMME SRL Registration: 3015173183 View Registration
Real View Imaging Ltd. Registration: 3015185750 View Registration
AIQ SOLUTIONS Registration: 3015200693 View Registration
AMCAD BIOMED CORPORATION Registration: 3015218501 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
ELEKTA SOLUTIONS AB Registration: 3015232217 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
S.M.A.I.O Registration: 3015383864 View Registration
Subtle Medical Inc Registration: 3015425142 View Registration
IRAY KOREA LIMITED Registration: 3015464948 View Registration
DURR DENTAL SE Registration: 3015509619 View Registration
Depuy Ireland UC Registration: 3015516266 View Registration
MEDIVIS, INC. Registration: 3015536273 View Registration
CLARIPI INC. Registration: 3015537315 View Registration
INTUITIVE SURGICAL, INC. Registration: 3015612252 View Registration
Philips Medical Systems Technologies Ltd. Registration: 3015763655 View Registration
Philips Medical Systems Nederland B.V. Registration: 3015777306 View Registration
I-MEDICAL ASIA COMPANY LIMITED Registration: 3015806723 View Registration
MEDENTIS MEDICAL GMBH Registration: 3015961056 View Registration
MULTIFUNCTIONAL IMAGING LLC Registration: 3016007746 View Registration
Blue Belt Technologies, Inc. Registration: 3016090213 View Registration
MEDIVIEW XR Registration: 3016110967 View Registration
LIFETRACK MEDICAL SYSTEMS PRIVATE LTD. Registration: 3016244609 View Registration
ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
SOFTWARE NEMOTEC, S.L. Registration: 3016446349 View Registration
QYNAPSE Registration: 3016450069 View Registration
ADAS3D MEDICAL S.L Registration: 3016461002 View Registration
FOCALYX TECHNOLOGIES Registration: 3016567400 View Registration
MEDICAL IP Co., Ltd. Registration: 3016579137 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
HEURON CO., LTD. Registration: 3016727312 View Registration
AXIAL MEDICAL PRINTING LIMITED Registration: 3016824824 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
IMPLANT PROTESIS DENTAL 2004, S.L. Registration: 3016954909 View Registration
IB LAB GMBH Registration: 3016965352 View Registration
RADISEN CO LTD Registration: 3017004860 View Registration
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD Registration: 3017058304 View Registration
OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) Registration: 3017102960 View Registration
NAVISWISS AG Registration: 3017123055 View Registration
CARISTO DIAGNOSTICS Registration: 3017140520 View Registration
uLab Systems, Inc Registration: 3017155477 View Registration
CLEERLY, INC Registration: 3017167291 View Registration
BRAINOMIX LIMITED Registration: 3017210169 View Registration
ARTRYA Registration: 3017233423 View Registration
SYS-MAC AUTOMATION ENGINEERING PTE LTD Registration: 3017263724 View Registration
4DMEDICAL LIMITED Registration: 3017426576 View Registration
SENTIAR, INC. Registration: 3017435704 View Registration
LABORIE MEDICAL TECHNOLOGIES CORP. Registration: 3017448360 View Registration
Vieworks Co., Ltd. Registration: 3017585294 View Registration
SPECTRAWAVE, INC. Registration: 3017654247 View Registration
Philips Ultrasound LLC Registration: 3017894900 View Registration
LIMBUS AI Registration: 3017927156 View Registration
Infervision Medical Technology Co., Ltd. Registration: 3017936680 View Registration
CARLSMED, INC. Registration: 3017936978 View Registration
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. Registration: 3017944270 View Registration
CARDIOWISE, INC. Registration: 3017991646 View Registration
DISIOR OY Registration: 3018064242 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
ARCHFORM, INC. Registration: 3018126402 View Registration
SIRONA MEDICAL, INC. Registration: 3018133052 View Registration
INHEART Registration: 3018302800 View Registration
A7 INTEGRATION Registration: 3018405359 View Registration
DEEPHEALTH Registration: 3018733944 View Registration
ULTRASPECT USA, LLC Registration: 3018788582 View Registration
UNIK ORTHOPEDICS, INC Registration: 3019006180 View Registration
Philips Ultrasound LLC Registration: 3019216 View Registration
Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
OVERJET Registration: 3019544554 View Registration
QMENTA Registration: 3019674997 View Registration
THERAPANACEA Registration: 3019834893 View Registration
CERCARE MEDICAL A/S Registration: 3019844085 View Registration
INSIGHT MEDICAL SYSTEMS, INC Registration: 3019878658 View Registration
Alphatec Spine, Inc. Registration: 3019878714 View Registration
SPINTECH, INC. Registration: 3020162557 View Registration
Arthrex New Zealand Limited Registration: 3020704423 View Registration
LAZARUS 3D, INC. Registration: 3020858025 View Registration
EverFortune.AI Co., Ltd. Registration: 3021032044 View Registration
REALIZE MEDICAL INC. Registration: 3021163566 View Registration
MEDIT CORP. Registration: 3021233709 View Registration
Dental Imaging Technologies Corporation Registration: 3021551875 View Registration
WHEELHOUSE MEDICAL Registration: 3021559833 View Registration
ASTUTE IMAGING Inc Registration: 3021625328 View Registration
MedCAD Registration: 3021635140 View Registration
HEARTFLOW, INC. Registration: 3021637148 View Registration
NICo-Lab B.V. Registration: 3021915828 View Registration
Intelerad USA Registration: 3022435840 View Registration
Ricoh 3D for Healthcare, LLC Registration: 3022973841 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
Arrow Rapac Ltd. Registration: 3023217364 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 3023245 View Registration
3D ONS, INC. Registration: 3023266032 View Registration
Philips DS North America LLC Registration: 3023385454 View Registration
iRay Imaging Technology (Haining) Limited Registration: 3023546785 View Registration
ASSEMBLECIRCLE CORP. Registration: 3023702877 View Registration
AKUNAH Registration: 3024040179 View Registration
SINGULAR HEALTH PTY LTD Registration: 3024078470 View Registration
Straumann Manufacturing, Inc. Registration: 3024185724 View Registration
SOFTSMILE, INC. Registration: 3024438491 View Registration
AIRS Medical Inc. Registration: 3024820186 View Registration
Megagen Implant Co., Ltd. (Seoul Branch) Registration: 3025029560 View Registration
ACUMED LLC Registration: 3025141 View Registration
AI4MedImaging Medical Solutions S.A. Registration: 3025308066 View Registration
QUIBIM S.L. Registration: 3025343020 View Registration
DEEPLOOK MEDICAL, INC Registration: 3025394753 View Registration
QPIX SOLUTIONS, INC. Registration: 3025442726 View Registration
NEUROPHET, INC. Registration: 3025602618 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
SMAART MEDICAL SYSTEMS, INC. Registration: 3025620599 View Registration
20MED PTE LTD Registration: 3026047529 View Registration
AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD. Registration: 3026309987 View Registration
IMAGE INSTRUMENTS GMBH Registration: 3026391019 View Registration
Covidien Registration: 3026612481 View Registration
VOXIMETRY Registration: 3026768398 View Registration
ICAD INC. Registration: 3026970882 View Registration
Advantis Medical Imaging Single Member P.C. Registration: 3027158439 View Registration
Insight Surgery Houston Registration: 3027329005 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 3027338963 View Registration
EZRA AI, INC. Registration: 3027347389 View Registration
Xironetic R&D Center Registration: 3027408258 View Registration
NANO-X IMAGING LTD Registration: 3027605321 View Registration
AVATAR MEDICAL Registration: 3027645731 View Registration
IMEKA SOLUTIONS INC. Registration: 3027977501 View Registration
CLEARADVANCE, LLC Registration: 3029877582 View Registration
CARDIO FLOW DESIGN INC. Registration: 3029906636 View Registration
VUNO INC. Registration: 3029915548 View Registration
DRGEM Corporation (Gimcheon Factory) Registration: 3029916061 View Registration
DENTI.AI TECHNOLOGY INC. Registration: 3029956998 View Registration
REBRAIN Registration: 3030088963 View Registration
TECHSOMED Registration: 3030089065 View Registration
MOTILENT LTD Registration: 3030179922 View Registration
ATOMICA TECHNOLOGY, INC Registration: 3030228551 View Registration
ONEPACS, LLC Registration: 3030228575 View Registration
ENHATCH, INC Registration: 3030409224 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
ICAT SOLUTIONS LTD Registration: 3030446518 View Registration
MYCARDIUM AI LTD Registration: 3030446846 View Registration
ORCA DENTAL AI Registration: 3030655434 View Registration
Ricoh 3D for Healthcare, LLC Registration: 3030977776 View Registration
CLARITAS HEALTHTECH LIMITED Registration: 3030979155 View Registration
IONIC HEALTH TECHNOLOGIES SA Registration: 3030982377 View Registration
CARPL.AI INC. Registration: 3031024978 View Registration
Biotronics 3D Limited Registration: 3031755019 View Registration
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registration: 3032008018 View Registration
Merge Canada Registration: 3032014234 View Registration
FUJIFILM SONOSITE,INC. Registration: 3032367 View Registration
SYNTHESIS HEALTH INTELLIGENCE INC. Registration: 3032579549 View Registration
GE Vingmed Ultrasound AS Registration: 3032807464 View Registration
GE Vingmed Ultrasound AS Registration: 3033508292 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
VUZE MEDICAL LTD. Registration: 3033524690 View Registration
Philips India Limited - Diagnostic X-ray Business Unit Registration: 3033525986 View Registration
Philips India Limited - Image Guided Therapy Systems Business Unit Registration: 3033525987 View Registration
Philips Global Business Services LLP - Ultrasound Business Unit Registration: 3033527241 View Registration
Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units Registration: 3033527273 View Registration
Philips India Limited - Image Guided Therapy Systems Business Unit Registration: 3033527282 View Registration
Philips India Limited - Ultrasound Business Unit Registration: 3033527283 View Registration
Philips India Limited - Diagnostic X-ray Business Unit Registration: 3033527770 View Registration
SOTA CLOUD CORPORATION Registration: 3034604691 View Registration
BRAINSPEC, INC Registration: 3035371452 View Registration
PEEK HEALTH, S.A. Registration: 3035455070 View Registration
AIRAMED GMBH Registration: 3035707772 View Registration
FOVIA, INC. Registration: 3036471119 View Registration
Q BIO Registration: 3036495186 View Registration
AUGMEDIT Registration: 3036725840 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
TAEYOUNG SOFT Registration: 3036758981 View Registration
Insight Surgery Nebraska Registration: 3038011206 View Registration
SPECTO MEDICAL AG Registration: 3038136320 View Registration
QFR SOLUTIONS BV Registration: 3038136528 View Registration
JLK, INC. Registration: 3038177848 View Registration
DEEPTEK MEDICAL IMAGING PVT. LTD Registration: 3038187462 View Registration
ROCLUB GMBH Registration: 3038189169 View Registration
MICROSTRUCTURE IMAGING, INC Registration: 3038191646 View Registration
ULTRAGREEN DATA SYSTEMS INC. Registration: 3040602603 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175844 View Registration
LAON MEDI INC. Registration: 3042204491 View Registration
SEE-MODE TECHNOLOGIES PTY LTD Registration: 3042248552 View Registration
APQ HEALTH INC Registration: 3042369547 View Registration
Ricoh 3D for Healthcare Registration: 3042480122 View Registration
DRIVING FORCE VMA, LLC Registration: 3042625805 View Registration
TELTONIKA EMS - Moletai Technology Center Registration: 3042957826 View Registration
maihub Corp. Registration: 3043532712 View Registration
GOOD METHODS GLOBAL INC. Registration: 3043840131 View Registration
ADVAHEALTH SOLUTIONS Registration: 3044519982 View Registration
ONTACT HEALTH CO., LTD. Registration: 3044776706 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
GE Healthcare Austria GmbH & Co OG Registration: 8020021 View Registration
Trophy Registration: 8020825 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
SION BIOTEXT MEDICAL LTD Registration: 8030128 View Registration
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration
Planmeca Oy Registration: 8030876 View Registration
SAMSUNG MEDISON CO., LTD. Registration: 8041160 View Registration
ESAOTE S.P.A. Registration: 8043485 View Registration
TOMTEC Imaging Systems GMBH Registration: 8043836 View Registration
BRAINLAB SE Registration: 8043933 View Registration
GE VINGMED ULTRASOUND A/S Registration: 9610482 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
KLS Martin SE & Co. KG Registration: 9610905 View Registration
GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration
MEDICAL MEASUREMENT SYSTEMS B.V. Registration: 9611896 View Registration
NOBEL BIOCARE AB Registration: 9611992 View Registration
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) Registration: 9612330 View Registration
BARCO N.V. Registration: 9613188 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 9613299 View Registration
STORZ MEDICAL AG Registration: 9613347 View Registration
GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration
Corin Limited Registration: 9614209 View Registration
MEDIS MEDICAL IMAGING SYSTEMS, B.V. Registration: 9614587 View Registration
CANON INC. Registration: 9614698 View Registration
SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration
VEPRO AG Registration: 9614981 View Registration
CARL ZEISS MEDITEC AG (OBERKOCHEN) Registration: 9615010 View Registration
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. Registration: 9615439 View Registration
INTELERAD MEDICAL SYSTEMS INCORPORATED Registration: 9615916 View Registration
SECTRA AB Registration: 9615992 View Registration
Visage Imaging GmbH Registration: 9616251 View Registration
AGFA HEALTHCARE N.V. Registration: 9616389 View Registration
Change Healthcare Israel Ltd. Registration: 9616760 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
ZIMMER CAS Registration: 9617840 View Registration
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. Registration: 9617978 View Registration
RAMSOFT, INC. Registration: 9680028 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
AGFA HEALTHCARE INC. Registration: 9680497 View Registration
ORTHOFIX SRL Registration: 9680825 View Registration
Philips Medical Systems Technologies Ltd. Registration: 9681475 View Registration
PIE MEDICAL IMAGING B.V. Registration: 9710122 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration
HERMES MEDICAL SOLUTIONS, AB Registration: 9710645 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-1172-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer