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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity TF PET/CT (nonRoHS)

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  Class 2 Device Recall Ingenuity TF PET/CT (nonRoHS) see related information
Date Initiated by Firm December 19, 2018
Create Date February 12, 2019
Recall Status1 Terminated 3 on August 03, 2021
Recall Number Z-0823-2019
Recall Event ID 82033
510(K)Number K172406  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ingenuity TF PET/CT (non-RoHS), Model Number 882456

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).
Code Information Serial Numbers 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/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-869-4807
Manufacturer Reason
for Recall		 A software update is being issued to correct multiple issues identified in the previous software version.
FDA Determined
Cause 2		 Software design
Action The firm, Philips, sent an "URGENT - Medical Device Correction" letters dated 12/19/18 to its customers. The letter describes the products, problem and actions to be taken. The customers were instructed to: review the information including (Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645) Software Issues) Issues with all members of your staff who need to be aware of the contents of this communication; retain a copy with the equipment Instruction for Use and If you need any further information or support concerning these issues, please contact your local Philips representative. or the Sr. Manager, Post Market Surveillance at 440-869-4807 or email: Holly.Lee@philips.com. 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 (nationwide) to states of: CA, IL, NY, OH, and PA; and to countries of: Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland.
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 = KPS and Original Applicant = Philips Medical Systems (Cleveland) Inc.
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