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
    30378
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-11
  • 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 separation of the tube and yoke assembly. carestream found a single device where four screws in the assembly were not applied in the manufacturing process. to date carestream has found only a single system where this failure has occured and considers it unlikely that there are other drx-revolution mobile x-ray systems where this step was missed. there was no injury associated with this failure.

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