Events

Recall of Device Recall GEMINI TF16 Diagnostic Imaging 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
    59175
  • Event Risk Class
    Class 2
  • Event Number
    Z-3199-2011
  • Event Initiated Date
    2011-05-31
  • Event Date Posted
    2011-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101503
  • 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 JAK
  • Reason
    The firm is conducting a recall/software correction to several of their gemini pet/ct x-ray system units in the field. the firm believes that if these software defects were to recur, it could impact the performance of reliability of the these pet/ct system units.
  • Action
    The firm , Philips Healthcare, issued a 'Customer Information Letter' dated August 9, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were not required to perform any action. A Philips' Field Service Engineer will visit each customer site and install the necessary software upgrade and Philips will track the progress of the software corrections as they take place. For customers in North America, if you need any further information or support concerning this update, please contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5 for "All Imaging Systems". Enter your site ID number. If you do not know your site ID, please hold and then select option 5 for "Nuclear Medicine" and finally select option 2 for "PET" support. In all other countries, the local Philips Healthcare office should be contacted at 440-483-3000.

Device

Device Recall GEMINI TF16 Diagnostic Imaging System
  • Model / Serial
    The recalled system units are identified as follows: Model Number: 882470, and Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.
  • Product Description
    Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine 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 CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • 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