Brilliance 64 Computed Tomography X-ray Systems Product Usage:… — Class II medical device recall Z-1872-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-06-08, distributed nationwide. The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
| Recall number | Z-1872-2016 |
|---|---|
| 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 | 2016-04-08 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CH, CN, CO, DE, EE, ES, FI, FR, GB, ID, IE, IL, IN, IT, JO, JP, KR, LB, LT, LV, MY, NL, NO, NZ, PA, PH, PL, PT, SE, SK, TH, TR, TW, VN, ZA |
| Quantity | 158 units |
| Model numbers | 728231 |
Product
Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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 became aware of a problem where the system may not map Varian drive after CT user logout/login.
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-1872-2016. 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.