BRILLIANCE VOLUME system — Class II medical device recall Z-1774-2021
Terminated recall by Philips North America Llc, reported 2021-06-09, distributed nationwide. Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
| Recall number | Z-1774-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-04-13 |
| Classified | 2021-06-02 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2022-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Serial numbers | 100100, 100434 |
| Model numbers | 728306 |
Product
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Reason for recall
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
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-1774-2021. 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.