Events

Recall of CARESTREAM DRX-1 SYSTEM WIRELESS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH CANADA COMPANY.

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
    45537
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-09
  • 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
    A single occurrence of a cross wired appliance connector within a carestream drx-1 system console was discovered during system testing prior to shipment. carestream has determined that a field inspection is necessary to ensure there are no consoles in the field with the cross wiring configuration. if a cross wired console is in use under the combination of circumstances where a facility does not have an intact electrical ground an operator or service person is touching the console and another grounded surface there could be a risk of severe electrical shock. this type of event is very unlikely as all of these circumstances must be true in order for the hazard to manifest.

Device

CARESTREAM DRX-1 SYSTEM WIRELESS
  • Model / Serial
    Model Catalog: 827 8186 (Lot serial: >10 numbers contact mfg); Model Catalog: 116 8079 (Lot serial: 181); Model Catalog: 8011199 (Lot serial: >10 numbers contact mfg)
  • Product Description
    Carestream DRX-1 System
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC