Events

Recall of Gemini GXL PET/CT scanner

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
    33273
  • Event Risk Class
    Class 2
  • Event Number
    Z-0068-06
  • Event Initiated Date
    2005-08-18
  • Event Date Posted
    2005-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41582
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Reason
    The image balance center point correction algorithm used in ct image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. this artifact may lead to the misinterpretation of anatomy at the center of the image.
  • Action
    The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.

Device

Gemini GXL PET/CT scanner
  • Model / Serial
    serial numbers 4001-4019.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.
  • Product Description
    Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)
  • 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