Events

Recall of GEMINI GXL PET/CT 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
    Recall
  • Event ID
    44934
  • Event Risk Class
    Class 2
  • Event Number
    Z-0462-2008
  • Event Initiated Date
    2007-09-21
  • Event Date Posted
    2008-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66521
  • 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
    PET/CT Diagnostic Imaging System - Product Code KPS
  • Reason
    Artifacts: artifacts may appear in some images from head scans on the ct subsystem of the gemini pet/ct system. reading images with these artifacts may lead to misdiagnosis or improper treatment.
  • Action
    Philips Medical notified domestic customers via Product Safety Notification dated May 30, 2007. The product safety notification includes a Technical Bulletin notifying customers of the issue and how to avoid it. This information will be used until the software correction becomes available. The software correction will be released in October 2008. Once software is available, the firm will begin correcting the field.

Device

GEMINI GXL PET/CT system
  • Model / Serial
    Gemini GXL    Product Numbers/Manufacturer Numbers: GXL 16 slice: 4535 679 71891, GXL 10 slice: 4535 679 75681, GXL 6 slice: 4535 679 75691.  Catalog Numbers: GXL 16 slice: 882410, GXL 10 slice: 882400, GXL 6 slice: 882390.   Serial Numbers: 4034-4159.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Australia, Belgium, Canada, China, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Netherlands, Poland, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Taiwan, Turkey, and Venezuela.
  • Product Description
    Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA