Philips Medical Systems (Cleveland) Inc
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
| Date | Mar 17, 2007 (initiated Oct 2, 2006) |
| Status | Terminated |
| Reason | Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data. |
| Root cause | Other |
| Action | Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction. |
| Quantity | 17 units |
| Distribution | Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |