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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 Recall
Ingenuity TF PET/CT
see related information
Date Posted April 01, 2013
Recall Status1 Terminated on June 18, 2013
Recall Number Z-1029-2013
Recall Event ID 64393
Premarket Notification
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, Ohio 44143-2131
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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