Events

Recall of DEFINIUM AMX 700 DIGITAL MOBILE SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    65563
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-13
  • 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
    This recall is due to an update by ge healthcare on the preventative maintenance and cleaning procedures of the exposure switches footswitches and hand switches of x-ray systems to address aggressive disinfectant procedures used by the users. the updates include recommended replacement of console switches every three years and recommends cleaning x-ray systems with cloth moistened in warm soapy water or cleaners approved by ge.

Device

DEFINIUM AMX 700 DIGITAL MOBILE SYSTEM
  • Model / Serial
    Model Catalog: S2000PA/PB (Lot serial: n/a); Model Catalog: S0910JB (Lot serial: n/a); Model Catalog: 5555000 (Lot serial: n/a); Model Catalog: 5555000-2 (Lot serial: n/a); Model Catalog: 2258627 (Lot serial: n/a); Model Catalog: 2275938-7 (Lot serial: n/a); Model Catalog: 2236420-7 (Lot serial: n/a); Model Catalog: 5555000-5 (Lot serial: n/a); Model Catalog: 5555000-6 (Lot serial: n/a); Model Catalog: 2169360-7 (Lot serial: n/a); Model Catalog: 46-270954G1 (Lot serial: n/a); Model Catalog: 46-270157G-1 (Lot serial: n/a); Model Catalog: 2115090-12 (Lot serial: n/a); Model Catalog: 2403791 (Lot serial: n/a); Model Catalog: 5555000-4 (Lot serial: n/a); Model Catalog: 5555000-3 (Lot serial: n/a); Model Catalog: 2407576 (Lot serial: n/a); Model Catalog: 46-329267G1 (Lot serial: n/a); Model Catalog: 2115090 (Lot serial: n/a)
  • Product Description
    DEFINUM AMX 700 DIGITAL MOBILE SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)