Brilliance iCT Product Usage: Computed Tomography X-ray systems… — Class II medical device recall Z-1004-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-01-18. Failure to correctly document the installation of four M12 Bolts into the system rotor.
| Recall number | Z-1004-2017 |
|---|---|
| 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 | 2016-11-25 |
| Classified | 2017-01-11 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2018-07-02 |
| Countries outside the US | CA |
| Quantity | 1 |
| Serial numbers | 100619, ROROT-45535-673-94382, SN26 |
| Model numbers | 728306 |
Product
Brilliance iCT Product Usage: Computed Tomography X-ray systems 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 analysts and display equipment, patient and equipment supports, components, and accessories
Reason for recall
Failure to correctly document the installation of four M12 Bolts into the system rotor.
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-1004-2017. 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.