Events

Recall of Device Recall Ingenuity TF PET/MR

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
    71882
  • Event Risk Class
    Class 2
  • Event Number
    Z-2491-2015
  • Event Initiated Date
    2015-07-23
  • Event Date Posted
    2015-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139267
  • 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
    Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
  • Reason
    Philips healthcare has become aware of a problem in which the ingenuity tf pet/mr pet reconstruction server (prs) database may lock up after an mr acquisition is completed and before a pet acquisition is begun, even though no actual database lockup issue has been reported in the field-installed ingenuity tf pet/mr systems.
  • Action
    On July 23, 2015 the firm sent Field Safety Notices to their customers.

Device

Device Recall Ingenuity TF PET/MR
  • Model / Serial
    M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
  • Product Description
    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical 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