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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity TF PET/CT

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  Class 2 Device Recall Ingenuity TF PET/CT see related information
Date Initiated by Firm December 20, 2012
Date Posted April 01, 2013
Recall Status1 Terminated 3 on June 18, 2013
Recall Number Z-1029-2013
Recall Event ID 64393
510(K)Number K052640  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ingenuity TF PET/CT.

Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Code Information Model #: 882456; Serial #: 2004
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Michael McAndrew
800-722-9377 Ext. 5
Manufacturer Reason
for Recall		 Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated December 19, 2012 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. A Philips Service Engineer will contact the customer for implementation of the software update on the affected system.
Quantity in Commerce 1
Distribution Distributed to one customer in Ohio.
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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