Recall Z-0332-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
| Date | Nov 8, 2017 |
| Status | Terminated |
| Reason | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. |
| Root cause | Device Design |
| Action | Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring |
| Quantity | 134 |
| Distribution | 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |