Brilliance CT 64 — Class II medical device recall Z-1649-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-06-03. The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpec
| Recall number | Z-1649-2015 |
|---|---|
| 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 | 2015-03-16 |
| Classified | 2015-05-22 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2017-02-22 |
| Countries outside the US | CN |
| Quantity | 153 units |
| Serial numbers | 10097, 10143, 10267, 10269, 10275, 10427, 10436, 10521, 10545, 10579, 10622, 90097, 90218, 95203, 95319, 95328, 95362, 95369, 95391, 95414, 95427, 95433, 95471, 95486, 95544 and 13 more |
Product
Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason for recall
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
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-1649-2015. 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.