Devices

Device Recall Fujifilm

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • Manufacturer Address
    Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA

16 devices with a similar name

Learn more about the data here

Device Recall Fujifilm
  • Model / Serial
    2500.0312.00 and 2500.0312.01
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide US and Canada
  • Product Description
    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). || For use in endoscopic procedures. Used to observe, record and capture images.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
Device Recall Fujifilm Aspire HD, Full Field Digital, System
  • Model / Serial
    Serial Number: 26320119
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in HI.
  • Product Description
    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; || Model: FOR MS-1000. || A mammography system used for screening and diagnosis of breast cancer.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
Device Recall Fujifilm Medical Systems
  • Model / Serial
    Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.
  • Product Description
    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular || Synapse Cardiovascular v4.0.8 || Synapse Cardiovascular v4.0.8 SR1 || Intended Use: || Picture Archiving and Communication System || Computer, Diagnostic, Programmable
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
Device Recall Fujifilm
  • Model / Serial
    Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide US and Canada
  • Product Description
    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
Device Recall FujiFilm
  • Model / Serial
    ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the US and Canada.
  • Product Description
    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
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