FDA Device recall Z-1774-2021
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body by Philips North America, citing cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1774-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-13 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Reason
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Identifiers
| code_info | Serial Numbers: 100100, 100434 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1774-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.