FDA Device recall Z-0332-2018
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
- FDA Device
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Philips Healthcare Brilliance iCT SP computed tomography x-ray system by Philips Medical Systems Cleveland, citing there is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0332-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-08 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Reason
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Identifiers
| code_info | Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present. |
|---|
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-0332-2018%22
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