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
    107098
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-21
  • 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 has identified an issue related to the drx-revolution mobile x-ray system where the boom arm can become loose. it has been determined that this issue is a result of an improperly assembled part which holds the x-ray tube assembly/boom to the device mounting block at the top of the column.

Device

DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Model / Serial
    Model Catalog: 1019397 (Lot serial: 101-764)
  • 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