Events

Recall of Device Recall Philips Healthcare Ingenuity TF PET/CT

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
    79004
  • Event Risk Class
    Class 2
  • Event Number
    Z-0522-2018
  • Event Initiated Date
    2017-11-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161069
  • 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
    One of the two wire channels mounted inside the gantry separation unit (gsu) that is also used to secure the top two gsu covers, was missing mounting hardware.
  • Action
    Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.

Device

Device Recall Philips Healthcare Ingenuity TF PET/CT
  • Model / Serial
    Ingenuity TF PET/CT Model # 882442
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One domestic and 1 foreign consignee ( Spain)
  • Product Description
    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
  • 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