Brilliance 6 — Class II medical device recall Z-0945-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-03-20, distributed nationwide. Philips Healthcare received reports from the field stating the patient table on a system had an unexpected dow
| Recall number | Z-0945-2013 |
|---|---|
| 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 | 2012-12-20 |
| Classified | 2013-03-13 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 4,797 units |
| Reason classes | device malfunction |
| Serial numbers | 10000, 10001, 100019, 10002, 100020, 100021, 100022, 100023, 100024, 100025, 100028, 10003, 100031, 100032, 100037, 100038, 100039, 10004, 100040, 100042, 100043, 100044, 100045, 100046, 100047 and 475 more |
Product
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices 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
Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.
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-0945-2013. 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.