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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/CTsee related information
Date Initiated by FirmDecember 20, 2012
Date PostedApril 01, 2013
Recall Status1 Terminated 3 on June 18, 2013
Recall NumberZ-1029-2013
Recall Event ID 64393
510(K)NumberK052640 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductIngenuity 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
FEI Number 1525965
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMichael 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
ActionPhilips 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 Commerce1
DistributionDistributed to one customer in Ohio.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPS
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