Devices

Device Recall Fujifilm

  • Modèle / numéro de série
    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
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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

Fabricant

Fujifilm Medical Systems U.S.A., Inc.
  • Adresse du fabricant
    Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA

16 dispositifs médicaux avec un nom similaire

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Device Recall Fujifilm
  • Modèle / numéro de série
    2500.0312.00 and 2500.0312.01
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide US and Canada
  • Description du dispositif
    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
  • Modèle / numéro de série
    Serial Number: 26320119
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in HI.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide US and Canada
  • Description du dispositif
    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.
Device Recall FujiFilm
  • Modèle / numéro de série
    ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the US and Canada.
  • Description du dispositif
    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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