Events

Recall of OEC 9900 ELITE C-ARMS - NON-CARDIAC

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
    25795
  • Event Risk Class
    II
  • Event Initiated Date
    2008-05-27
  • 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
    Software design defect results in failure to apply entrance exposure rate ma limits calibration to automatic exposure rate control system when anatomical profile mode is changed from default selection.

Device

OEC 9900 ELITE C-ARMS - NON-CARDIAC
  • Model / Serial
    Model Catalog: S2024MR (Lot serial: E9-0148 ES-7019-CMH); Model Catalog: S2024MM (Lot serial: E9-0148 ES-7019-CMH); Model Catalog: S2024MR (Lot serial: S/N'S E9-0027 E9-0087); Model Catalog: S2024MM (Lot serial: S/N'S E9-0027 E9-0087); Model Catalog: S2024MM (Lot serial: E2-0118-MH E2-7026-MH); Model Catalog: S2024MY (Lot serial: S/N'S E2-0065 E2-0073); Model Catalog: S2024MM (Lot serial: S/N'S E2-0065 E2-0073); Model Catalog: S2024MR (Lot serial: E2-0118-MH E2-7026-MH); Model Catalog: S2024MY (Lot serial: E2-0118-MH E2-7026-MH); Model Catalog: S2024MR (Lot serial: S/N'S E2-0065 E2-0073)
  • Product Description
    OEC 9900 ELITE C-ARMS - NON CARDIAC
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)