Events

Recall of Smart CR Digital Computed Radiography System

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
    73668
  • Event Risk Class
    Class 2
  • Event Number
    Z-1599-2016
  • Event Initiated Date
    2016-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144696
  • 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
    Processor, radiographic-film, automatic - Product Code IXW
  • Reason
    Reports of failure of the device's power supply.
  • Action
    Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.

Device

Smart CR Digital Computed Radiography System
  • Model / Serial
    All serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
  • 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., 419 West Ave, Stamford CT 06902-6343
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA