Devices

Device Recall Fujifilm

  • Model / Serial
    For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Fujifilm Endoscope || Model ED-530XT || Product Usage: || This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
  • 1 Event

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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