• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity TF

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Ingenuity TF see related information
Date Initiated by Firm December 11, 2017
Create Date February 09, 2018
Recall Status1 Terminated 3 on August 30, 2022
Recall Number Z-0562-2018
Recall Event ID 79008
510(K)Number K172406  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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
Code Information 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 
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
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)
Quantity in Commerce 24
Distribution Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Philips Medical Systems (Cleveland) Inc.