Events

Recall of GEMINI TF 64 PET/CT SYSTEM - PET SUBSYSTEM

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
    56729
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-14
  • 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
    If 80 kvp is selected for a low dose ct on a gemini 64 pet/ct during the pet acquisition the concurrent reconstruction will fail and the customer may think that their images were lost. this may cause the customer to re-scan the patient.

Device

GEMINI TF 64 PET/CT SYSTEM - PET SUBSYSTEM
  • Model / Serial
    Model Catalog: 4535 679 81361 (Lot serial: )
  • Product Description
    GEMINI TF 64 PET/CT SYSTEM - PET SUBSYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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