FDA Device Recall Z-1269-2024: FUJIFILM Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1269-2024.

Recall Res Number

Z-1269-2024

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

3 Units (3 US)

Product Description Synapse PACS - Version 7.1.000US

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: 7.1.000US, UDI: (01)854904006008(10)0701000US

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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-1269-2024

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