Class 2 Device Recall Ingenuity TF PET/CT

• Date Initiated by Firm: January 21, 2013
• Date Posted: February 28, 2013
• Recall Status: Terminated on July 19, 2013
• Recall Number: Z-0897-2013
• Recall Event ID: 64403
• 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.
• FEI Number: 1525965
• 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: 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: 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 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