Recall Z-0897-2013 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT. Diagnostic imaging system
| Date | Feb 28, 2013 (initiated Jan 21, 2013) |
| Status | Terminated |
| Reason | The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients. |
| Root 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 | 1 Unit |
| Distribution | Distributed only in Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |