Events

Recall of Device Recall The MXR35 Xray Generator's.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujifilm Medical System USA, 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
    67958
  • Event Risk Class
    Class 2
  • Event Number
    Z-1642-2014
  • Event Initiated Date
    2012-06-29
  • Event Date Posted
    2014-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126664
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Reason
    The mxr-35 x-ray generator's labeling did not include the certification statement as required by 21 cfr part 10 10.2.
  • Action
    Fujifilm will replace the violative labels with replacement labels provided by DRGEM, to bring the X-ray generator into compliance. You stated that you expect for all nine installed units to be corrected by the end of May 2014. The seven units in the Stamford, CT warehouse will be corrected when the generators are delivered to customer sites. Under 21 CFR 1003.31(c)(2), this exemption is granted subject to the following conditions: 1. You must correct the missing certification statement for all units shipped into the US within the timeline you specified, by the end of May 2014. 2. You must ensure that all future units that will be delivered and installed in the US will be in compliance with the labeling requirement, per 21 CFR 1010.2.

Device

Device Recall The MXR35 Xray Generator's.
  • Model / Serial
    SN: MXA1170108, MXA1270262
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
  • Product Description
    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. || x-ray generator
  • Manufacturer
    Fujifilm Medical System USA, Inc.

Manufacturer

Fujifilm Medical System USA, Inc.
  • Manufacturer Address
    Fujifilm Medical System USA, Inc., 419 West Ave, Stamford CT 06902-6343
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA