Events

Recall of VENTRI DUAL DETECTOR CARDIAC GAMMA CAMERA - 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
    18410
  • Event Risk Class
    III
  • Event Initiated Date
    2012-12-20
  • 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
    During a patient unload following a scan the patient's fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.

Device

VENTRI DUAL DETECTOR CARDIAC GAMMA CAMERA - MAIN UNIT
  • Model / Serial
    Model Catalog: H3000ZF (Lot serial: > 10 lot numbers contact mfg); Model Catalog: S8000RA (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    Ventri Dual Detector Cardiac Gamma Camera Nuclear Imaging System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)