Brilliance iCT — Class II medical device recall Z-1058-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-02-01. During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt
| Recall number | Z-1058-2017 |
|---|---|
| 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 | 2016-12-23 |
| Classified | 2017-01-20 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-06-26 |
| Countries outside the US | AU |
| Quantity | 1 |
Product
Brilliance iCT
Reason for recall
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
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-1058-2017. 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.