Events

Recall of SIGNA PIONEER

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
    81008
  • Event Risk Class
    II
  • 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. fmi 60903. images may exhibit novel artifacts on magic t2 flair synthetic reconstructions that may be difficult to recognize without access to conventional t2 flair weighted images. this issue has the potential to lead to misinterpretation of the magic images when making medical diagnosis or treatment decisions. magic acquisition is unique in that all contrasts are acquired simultaneously therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artifacts. there have been no injuries reported as a result of this issue.

Device

SIGNA PIONEER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)