Recall Z-0067-2014 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specifi
| Date | Oct 25, 2013 (initiated Aug 16, 2013) |
| Status | Terminated |
| Reason | Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical. |
| Root cause | Software design |
| Action | Philips Healthcare sent an Field Safety Notice dated August 16. 3013, via certified mail to all US customers. Market Representative will distribute the letter internationally. The letter identified the product the problem and the action needed to be taken by the customer. Field Safety Notice 88200460 is intended to inform you about; " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem Additionally, a Field Service Engine |
| Quantity | 13 |
| Distribution | Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |