Events

Recall of Positron Emission Tomography (PET) and Xray Computed Tomography

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
    62892
  • Event Risk Class
    Class 2
  • Event Number
    Z-2239-2012
  • Event Initiated Date
    2012-08-08
  • Event Date Posted
    2012-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111947
  • 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 became aware of an issue relating to a ups battery cabinet that appeared to have burned a hole through the casing on one of the batteries. supplier of the ups, chloride/emerson, determined the batteries, housed within the ups battery cabinet, entered thermal runaway causing the battery to overheat.
  • Action
    Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated August 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Field Service Engineers will be implementing a Field Change Order (FCO) to replace the batteries of the affected UPS units. Contact the Philips Healthcare Customer Care Solutions Center at 1-800-722-9377 for questions regarding this notice. .

Device

Positron Emission Tomography (PET) and Xray Computed Tomography
  • Model / Serial
    GEMINI TF 16 System serial numbers: 7194, 7186, 7235, 7233 GEMINI GXL 16 System serial number: 4201 GEMINI TF Big Bore System serial numbers: 9022, 9201
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.
  • Product Description
    Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. || The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: " The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. " The detection, localization, and staging of tumors and diagnosing cancer patients. " Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.
  • 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