Events

Recall of Device Recall Fujifilm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujifilm Medical Systems U.S.A., Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76899
  • Event Risk Class
    Class 2
  • Event Number
    Z-2706-2017
  • Event Initiated Date
    2017-02-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154531
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gastroscope and accessories, flexible/rigid - Product Code FDS
  • Reason
    Fujifilm is recalling multiple endoscopes after a retrospective review.
  • Action
    Fujifilm sent an Urgent - Medical Device Removal letter dated February 17, 2017. Customers are provided information regarding the recall and asked to complete the attached form and return to Fujifilm. Questions can be directed to sales representative. For further questions, please call (973) 709-2202.

Device

Device Recall Fujifilm
  • Model / Serial
    1U881A131 1U88A1A145 3U881A005
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to : AL, HI and MO
  • Product Description
    Ultrasonic Endoscope || Model Number EG-530UT || A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

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