Events

Recall of GEMINI TF 16 PET/CT SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    80093
  • Event Risk Class
    II
  • Event Initiated Date
    2008-01-18
  • 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
    When the operator uses the distance or area measurement functions on zoomed and batched saves images from the cardiac viewer or pulmonary viewer and then views then in ct viewer measurements are incorrect.

Device

GEMINI TF 16 PET/CT SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4535 679 83931 (Lot serial: S/N 7049); Model Catalog: 4535 679 71891 (Lot serial: S/N 4045); Model Catalog: 4535 679 71891 (Lot serial: S/N 4132); Model Catalog: 4535 674 41711 (Lot serial: S/N 7049); Model Catalog: 4535 679 94741 (Lot serial: S/N NOT PROVIDED CONTACT MFG); Model Catalog: 4535 674 41721 (Lot serial: S/N NOT PROVIDED CONTACT MFG)
  • Product Description
    GEMINI TF 16 PET/CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC