Events

Recall of Device Recall GEMINI PET/CT diagnostic imaging systems

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
    53517
  • Event Risk Class
    Class 2
  • Event Number
    Z-0261-2010
  • Event Initiated Date
    2009-01-26
  • Event Date Posted
    2009-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85709
  • 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
    Emission computed tomography system - Product Code JAK
  • Reason
    Upper patient pallet component of the recalling firm's gemini pet/ct system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
  • Action
    The firm notified customers with an "URGENT - Field Safety Notice" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring patients before, during, and after scanning studies. The notice goes on to inform the customers that replacement parts for the upper patient pallet(s) are on order and that a Philips Healthcare Field Service Engineer will be visiting each customer site within two (2) months in order to replace each affected pallet. Lastly, the notification provides a toll-free telephone number and instructions which the customer can use to contact a local Philips representative if additional information, or assistance is required. The firm's Customer Care Center contact is 1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology.

Device

Device Recall GEMINI PET/CT diagnostic imaging systems
  • Model / Serial
    Catalog Numbers: 882470, 882471, and 882473; Model Numbers: 4535 679 83931 , 4525 679 94741, and 4535 674 41711; and Serial Numbers: 7096, 7139, 7144, 7145, 7146, 7148, 7149, 7150, and 7151.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea.
  • Product Description
    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640
  • 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