Philips Brilliance 6 — Class II medical device recall Z-2035-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-07-25, distributed nationwide. Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carb
| Recall number | Z-2035-2012 |
|---|---|
| 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 | 2012-07-02 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BR, CA, CL, CN, CZ, DE, DK, DO, EC, EG, ES, FR, GB, GR, ID, IN, IQ, IS, IT, JO, KR, MX, MY, NG, NL, NO, NZ, PE, PK, PL, PT, RU, SA, SE, SG, SK, TH, TR, TW, VE, VN, ZA |
| Quantity | 524 |
| Reason classes | device malfunction |
| Serial numbers | 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138 and 475 more |
Product
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography 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
Reason for recall
Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.
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-2035-2012. 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.