Events

Recall of Device Recall Gemini 16, GS, GXL, Precedence.

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
    37567
  • Event Risk Class
    Class 2
  • Event Number
    Z-0013-2007
  • Event Initiated Date
    2006-11-06
  • Event Date Posted
    2007-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50795
  • 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 computed tomography system - Product Code KPS
  • Reason
    A potential anomaly was identified on the ct subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
  • Action
    The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.

Device

Device Recall Gemini 16, GS, GXL, Precedence.
  • Model / Serial
    Serial #s:  4034-4100, 4102, 4103, 1041
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
  • Product Description
    Nuclear medicine systems: || Gemini 16, Model 4535 679 28961. || Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. || Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. || PET/CT Computed tomography systems.
  • 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