Recall Z-1461-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
| Date | Apr 16, 2014 (initiated Mar 27, 2014) |
| Status | Terminated |
| Reason | Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe. |
| Root cause | Nonconforming Material/Component |
| Action | A Field Safety Notice was sent to all US consignees via certified mail. Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. |
| Quantity | 135 |
| Distribution | Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |