Events

Recall of Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore

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
    68643
  • Event Risk Class
    Class 2
  • Event Number
    Z-2037-2014
  • Event Initiated Date
    2014-06-18
  • Event Date Posted
    2014-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128391
  • 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
    When beginning a procedure to start the gantry and ct host, a close estop message may appear to the operator, but disappears before action can be taken. if this occurs it results in an inability to close e-stop and the system is not operational for clinical use. this problem occurs randomly.
  • Action
    Philips Healthcare is informing the consignee of this issue through a Field Safety Notice (FSN) 88200487-488. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update.

Device

Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore
  • Model / Serial
    GEMINI TF PET/CT16: 882470 7019,7039,7099,7588,7593,7598,7599,7600,7604,7605,7596M  GEMINI TF PET/CT 64: 882471 7027,7044,7146,7153,7178,7182,7188,7578,7579,7585,7587,7589,7592,7594,7595,7602, 7603, 7606  GEMINI TF Big Bore: 882476 9019,9227,9232,9233
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, CO, IL, OK, OR and WI.
  • Product Description
    GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA