Recall of Device Recall GEMINI TF 16 Slice CT/PET System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    Philips has identified four (4) software defects in the tumor loc software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
  • Action
    On 7/6/2015 the firm sent Field Safety Notices to their customers.


  • Model / Serial
    Model #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.
  • Product Description
    GEMINI TF 16 Slice CT/PET System. || The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
  • Manufacturer


  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source