Recall Z-1058-2017 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT
| Date | Dec 23, 2016 |
| Status | Terminated |
| Reason | During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued. |
| Root cause | Employee error |
| Action | Philips sent an Customer Information letter. A document showed an incorrect torque wrench used during the assembly process which could potentially apply 4 Newton-meters less torque than specified to the system rotor counterweight bolts. Out of an abundance of caution, Philips will have a Field Service Engineer ensure the bolts on your system are correctly torqued. If you need any further information or support concerning this issue, please contact your local Philips representative. For further information please call (440) 483-5777. |
| Quantity | 1-unit |
| Distribution | Product was not distributed in the US. Unit was distributed in Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |