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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Ingenuity TF PET/CT		see related information
Date Posted February 28, 2013
Recall Number Z-0897-2013
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
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.
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.
 
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