Recall Z-0402-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
| Date | Jul 11, 2017 |
| Status | Terminated |
| Reason | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions. |
| Root cause | Software design |
| Action | A Customer Information Letter dated June 29, 2017, was sent to US consignees via certified mail. 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. |
| Quantity | 559 total |
| Distribution | Worldwide distribution, including US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |