Brilliance 64 — Class II medical device recall Z-0389-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-01-24. Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specificat
| Recall number | Z-0389-2018 |
|---|---|
| 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 | 2017-11-10 |
| Classified | 2018-01-18 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2020-11-05 |
| Countries outside the US | AR, CN, GB, KR, SK, TR |
| Quantity | 1 |
Product
Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason for recall
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
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-0389-2018. 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.