Ingenuity TF PET/CT. Diagnostic imaging system
FDA Recall Z-0897-2013 · Posted 2013-02-28
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2013-01-21
Date Terminated2013-07-19
Product Quantity1 Unit
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distributed only in Ohio.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.