The Brilliance 6 — Class II medical device recall Z-2245-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-08-29, distributed nationwide. The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on
| Recall number | Z-2245-2012 |
|---|---|
| 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 | 2012-08-03 |
| Classified | 2012-08-22 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, CN, DE, DK, FR, GB, IS, JP, NL, SE, ZA |
| Quantity | 126 units |
| Serial numbers | 10009, 10011, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10133, 10135, 10136 and 90 more |
Product
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
Reason for recall
The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
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-2245-2012. 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.