Events

Recall of Philips Medical Systems GEMINI TF 16 PET/CT System &38; GEMINI TF 64 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
    60969
  • Event Risk Class
    Class 2
  • Event Number
    Z-0937-2012
  • Event Initiated Date
    2011-10-24
  • Event Date Posted
    2012-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106911
  • 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 KPS
  • Reason
    Philips became aware of an issue relating to a ups cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.
  • Action
    Philips Medical Systems (Cleveland) Inc communitcated the problem to the facilities via telephone. No customer letter was sent since the correction was already performed by the supplier.

Device

Philips Medical Systems GEMINI TF 16 PET/CT System &38; GEMINI TF 64 PET/CT System
  • Model / Serial
    GEMINI TF 16 Serial Number 7224 & GEMINI TF 64 Serial Number 7217
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Maryland and Colorado
  • Product Description
    GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, 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, head, 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. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
  • 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