Recall Z-0518-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Philips Brilliance 64 computed tomography x-ray system
| Date | Oct 6, 2017 |
| Status | Terminated |
| Reason | Numerous issues related to software Brilliance iCT 4.1.6 software version. |
| Root cause | Software design |
| Action | Philips Medical Systems (Cleveland), Inc. sent the Customer Information Letter via certified letters mail with returned receipts. Also, a Field Service Engineer will perform the software update on the system to resolve the issues. Implementation of the software update will be monitored. |
| Quantity | 1801 |
| Distribution | 26 US Govt accounts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160743 | Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc., Aug 8, 2016 |