FDA Device Recall Z-1270-2024: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1270-2024.

Recall Res Number

Z-1270-2024

Recalling Firm / Manufacturer

FUJIFILM Healthcare Americas Corporation

FEI Number

1000513161

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-01-10

Date Posted

2024-03-07

Date Terminated

N/A

Product Code

LLZ

Event Number

94090

Product Quantity

19 Units (7 US, 12 OUS)

Product Description Synapse PACS - Version 7.2.000

Reason for Recall Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Action Details URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers January 26, 2024. In an abundance of caution, FUJIFILM is recommending that customer/end users take one of the following actions until the correction is applied: 1. To not perform measurements on Secondary Capture Images that are displayed together with Breast Tomo Images. 2. Ensure Secondary Capture Image has valid pixel spacing values using the DICOM Header Tool. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken. Please contact our 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. Please keep a copy of this letter with your instructions for use.

Distribution Pattern Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.

Code Information / Serial Numbers Software Version: 7.2.000, UDI: (01)854904006008(10)0702000

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ONYX MEDICAL LLC Registration: 1043653 View Registration
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CDB CORPORATION Registration: 1054415 View Registration
REMINGTON MEDICAL, INC. Registration: 1056553 View Registration
KLS-Martin L.P. Registration: 1057946 View Registration
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Konica Minolta Healthcare Americas, Inc Registration: 1064396 View Registration
FORESIGHT IMAGING, LLC Registration: 1064588 View Registration
SYNTERMED, INC. Registration: 1066019 View Registration
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ARTHREX, INC. Registration: 1220246 View Registration
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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
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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
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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
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PARAGON MEDICAL, INC. Registration: 1834331 View Registration
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BIOSEAL Registration: 2027062 View Registration
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OSTEOMED Registration: 2027754 View Registration
VISION CHIPS, INC. Registration: 2031081 View Registration
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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
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FUJIFILM CORPORATION Registration: 3001722928 View Registration
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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
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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
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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
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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
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SOFTLINK INTERNATIONAL PVT. LTD. Registration: 3003989043 View Registration
INFINITT HEALTHCARE CO., LTD. Registration: 3003989064 View Registration
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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
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DONSON MACHINE COMPANY Registration: 3004153896 View Registration
INDUSTRIAS MEDICAS SAMPEDRO S.A.S Registration: 3004187715 View Registration
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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
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3D INDUSTRIAL IMAGING CO., LTD. Registration: 3004755841 View Registration
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. Registration: 3004756607 View Registration
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DIO Corporation Registration: 3007126709 View Registration
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Varian Medical Systems, Inc. Registration: 3007157255 View Registration
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IMAGING BIOMETRICS, LLC Registration: 3007225492 View Registration
CIRCLE CARDIOVASCULAR IMAGING INC Registration: 3007301305 View Registration
HALIFAX BIOMEDICAL INC. Registration: 3007305589 View Registration
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Planet DDS Registration: 3007350723 View Registration
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MOSER-BAER AG Registration: 3007441485 View Registration
TRILLIUM TECHNOLOGY, INC Registration: 3007457520 View Registration
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MIRADA MEDICAL LIMITED Registration: 3007697958 View Registration
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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
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ANATOMAGE, INC. Registration: 3008272529 View Registration
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EvERX PTY LTD Registration: 3008496839 View Registration
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Hyland Software, Inc. Registration: 3008596921 View Registration
Nobel Biocare Services AG Registration: 3008693672 View Registration
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LUNIT INTERNATIONAL LIMITED Registration: 3009117933 View Registration
RadmediX, LLC Registration: 3009134655 View Registration
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NUVASIVE, INC. Registration: 3009144915 View Registration
ORTHO2 Registration: 3009149931 View Registration
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Agfa HealthCare Registration: 3009238175 View Registration
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PAXERAHEALTH CORP Registration: 3009341091 View Registration
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Materialise Ukraine, Rep. office Registration: 3009555440 View Registration
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STERIPACK USA (LIMITED) LLC Registration: 3009656988 View Registration
iCRco Inc. Registration: 3009717300 View Registration
ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
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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
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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
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PIXMEO SARL Registration: 3012516536 View Registration
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TAMUZ F.T.K. SOLUTIONS Registration: 3012911444 View Registration
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Dymax, Corp. Registration: 3013041594 View Registration
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RESOUNDANT, INC. Registration: 3013695852 View Registration
EXOCAD AMERICA, INC. Registration: 3013718526 View Registration
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DANELIS MEDICAL LIMITED Registration: 3013844297 View Registration
INTEWARE CO., LTD Registration: 3013912897 View Registration
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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
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KLS MARTIN MANUFACTURING, LLC Registration: 3014483751 View Registration
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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
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ASCEND CARDIOVASCULAR LLC Registration: 3015168097 View Registration
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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
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S.M.A.I.O Registration: 3015383864 View Registration
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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
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ARTRYA Registration: 3017233423 View Registration
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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

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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-1270-2024

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