Brilliance CT 16 — Class II medical device recall Z-1461-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-04-23, distributed nationwide. Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the
| Recall number | Z-1461-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2014-03-27 |
| Classified | 2014-04-16 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2016-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 135 |
| Reason classes | device malfunction |
| Serial numbers | 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, 100507, 10805, 10806, 300165, 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154 and 109 more |
| Model numbers | 728231, 728243, 728244, 728246, 728306, 728317, 728321, 728323, 728326 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.