Events

Recall of Device Recall Ingenuity TF

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
    79008
  • Event Risk Class
    Class 2
  • Event Number
    Z-0562-2018
  • Event Initiated Date
    2017-12-11
  • 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=161075
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    A software issue causes pet reconstructions to fail intermittently. it was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. this error has been found to occur in two scenarios: 1) when the system operator cancels an acquisition a. the error will occur every time a scan is cancelled by the operator. 2) couch position requests within the software sequence were delayed a. the error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. the error manifests to the technologist by an error message and failed status on the reconstruction monitor and the error message result {0} failed to reconstruct" on the acquisition workflow window during reconstruction after the patient scan has been completed. in both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.
  • Action
    Philips Healthcare sent an Urgent-Field Safety Notice dated December 11, 2017. U.S. Customers will be receive the letter via USPS Certified mail. Non-U.S.. customers will receive the letter through Philips Global Markets following local regulations. Philips is informing customers of the software issues on the systems, as well as available workarounds to prevent these issues from occurring or to minimize their impact. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts)

Device

Device Recall Ingenuity TF
  • Model / Serial
    Ingenuity TF PET/CT (model 882442) SN: 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
  • Product Description
    Ingenuity TF PET/CT (model 882442) running software version 4.0.2 || This device is a diagnostic imaging system that combines 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). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
  • 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