Events

Recall of REVOLUTION CT - MAIN UNIT

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
    75441
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-23
  • 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
    The following issue is being addressed by ge healthcare file no. 25470. the revolution ct exceeds iec conducted emission requirements. during recent certification testing ge healthcare determined that one configuration of the revolution ct product exceeds the conducted emissions limits specified in the iec60601-1-2:2007 emc standard. medical devices powered on the same power line as the revolution ct power distribution unit (pdu) may be affected by electrical emissions through the power line. equipment powered from the ct system such as the ekg monitor or patient contrast injector are not affected.

Device

REVOLUTION CT - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)