Recall Z-1056-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
| Date | Feb 17, 2012 (initiated Dec 13, 2011) |
| Status | Terminated |
| Reason | A number of non-conformances have been noted in the TruFlight Select PET/CT System. A number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units. |
| Root cause | Software design |
| Action | Philips sent an 'URGENT - Medical Device Correction TruFlight Select PET/CT Serial Numbers: 17002, 17003 letters. The letter was dated December 13, 2011. The letter describes the affected product, the nature of the problem along with the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. In this case, the customers (operator/users) are provided with separate recommended actions. The letter goes on to notify the customers that a Philips representative will be visiting each customer site and installing a software update (3.5. |
| Quantity | two (2) units were distributed |
| Distribution | Nationwide Distribution -- OH and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |