Events

Recall of DRX-REVOLUTION MOBILE X-RAY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH 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
    16332
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Carestream health has identified an issue with the drx-revolution mobile x-ray system that could result in unintended motion. carestream's investigation found that the pivot screws in the drive handle can back out and interfere with the driving mechanism. the backed out screw can interfere with operator control of the drx revolution and result in unintended motion. the investigation revealed that thread locking compound applied in the manufacturing process to secure this screw was not always applied as it should. to date carestream has found only a single system where this failure has occurred there was no resulting injury but the problem could manifest in additional units over the life of the device.

Device

DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Model / Serial
    Model Catalog: 1019397 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Manufacturer
    CARESTREAM HEALTH INC.

Manufacturer

CARESTREAM HEALTH INC.
  • Manufacturer Address
    ROCHESTER
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC