FDA Device recall Z-1058-2017
Brilliance iCT
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Brilliance iCT by Philips Medical Systems Cleveland, citing during a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1058-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-23 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Brilliance iCT
Reason
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Identifiers
| code_info | Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1058-2017%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.