Events

Recall of Ingenuity TF PET/MRI 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
    61809
  • Event Risk Class
    Class 2
  • Event Number
    Z-1646-2012
  • Event Initiated Date
    2012-04-13
  • Event Date Posted
    2012-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109141
  • 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
    Software errors. a number of non-conformances were identified and corrected by philips medical for their ingenuity tf pet/mri systems running software version 3.7.1. the firm states that these non-conformances stemmed from software and/or documentation errors, and that software corrections are being performed in order to 'improve the overall quality and functionality of the ingenuity tf ct/mri s.
  • Action
    The firm, Philips Medical, sent an 'URGENT - Medical Device Correction' notification letter dated April 13, 2012 to all affected customers via Certified mail. The letter informs the customers of the firm's upcoming software update. It tells the customers that the software for the Ingenuity TF PET/MR system unit will be upgraded from version 3.7.1 to version 3.7.2 and that the update/upgrade will provide a number of improvements to the overall quality and functionality of the Ingenuity TF PET/MR System. The notification document states that Philips will be installing the system update to version 3.7.2 software through a Field Change Order. This will be implemented free-of-charge and will include complementary PET/MR application training. For further information, call toll-free telephone number which they can call 1-800-722-9377 and follow the menu options to reach a Customer Solutions Engineer.

Device

Ingenuity TF PET/MRI System
  • Model / Serial
    Serial Numbers 11004-11014 are subject to recall/software correction.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and Switzerland.
  • Product Description
    Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. || The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.
  • 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