Events

Recall of DISCOVERY NM/CT 670 PRO

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
    48225
  • Event Risk Class
    III
  • Event Initiated Date
    2017-05-17
  • 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 become aware of a potential safety issue that can result in a scan starting before the prescribed delay has completed. more specifically if an exam is interrupted during the prep delay period using the emergency stop button and the scan is then resumed the delay period may be shorter than expected. if personnel are in the scan room at the time of the premature scan initiation they can be exposed to scatter x-ray radiation.

Device

DISCOVERY NM/CT 670 PRO
  • Model / Serial
    Model Catalog: H3100AD (Lot serial: 27115); Model Catalog: H3100AD (Lot serial: 27124); Model Catalog: H3100JN (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: H3100AD (Lot serial: PROV27146); Model Catalog: H3100AD (Lot serial: 27051); Model Catalog: H3100AE (Lot serial: 28008); Model Catalog: H3100AD (Lot serial: 000000SAN00776); Model Catalog: H3100AD (Lot serial: 27081); Model Catalog: S8000RD (Lot serial: 00000000019102)
  • Product Description
    DISCOVERY NM/CT 670 PRO;DISCOVERY NM/CT 670;DISCOVERY NM/CT 670 ES;DISCOVERY NM/CT 570C
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)