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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 February 28, 2013
Recall Status1 Terminated on July 19, 2013
Recall Number Z-0897-2013
Recall Event ID 64403
Premarket Notification
510(K) Number
K052640 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Ingenuity TF PET/CT. Diagnostic imaging system
Code Information Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Michael McAndrew
800-722-9377 Ext. 5
Manufacturer Reason
for Recall
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Medical Systems (Cleveland), Inc. sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated January 21, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact your local Philips representative or Philips Healthcare office for further information concerning this issue.
Quantity in Commerce 1 Unit
Distribution Distributed only 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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