Events

Recall of HAWKEYE

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
    15693
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-23
  • 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
    Ge healthcare has recently performed a field action on ge healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. as part of this field action ge healthcare updated the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners.

Device

HAWKEYE
  • Model / Serial
    Model Catalog: H3000WZ (Lot serial: >10 contact mfg.); Model Catalog: H3000YM (Lot serial: >10 contact mfg.); Model Catalog: H3000YS (Lot serial: >10 contact mfg.); Model Catalog: H3000WT (Lot serial: >10 contact mfg.); Model Catalog: H3000WW (Lot serial: >10 contact mfg.); Model Catalog: H3000WC/WD (Lot serial: >10 contact mfg.); Model Catalog: H3100RC (Lot serial: >10 contact mfg.); Model Catalog: H3000YA (Lot serial: >10 contact mfg.); Model Catalog: 5368012 (Lot serial: >10 contact mfg.)
  • Product Description
    Hawkeye Option for Dual Head Variable Angle Gamma Camera
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)