Recall Z-1285-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
| Date | Mar 23, 2012 (initiated Feb 17, 2012) |
| Status | Terminated |
| Reason | A number of non-conformances were identified during internal and external validation testing of the Brilliance 64 and Ingenuity CT systems with software version Beta 3 (version 4.0.0.xx368). |
| Root cause | Software change control |
| Action | Philips Healthcare sent an Urgent Medical Device Correction letter dated February 17, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of the contents in the communication. Customers were asked to retain a copy of the communication with the equipment instruction for Use. For further information or support concerning this issue, customers should contact their local Philips representativ |
| Quantity | 7 units |
| Distribution | Worldwide Distribution - USA including OH and the following countries: Australia, China, Belgium, Israel & Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |