FDA Device recall Z-1695-2015
Brilliance iCT Computed Tomography X-ray system
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Brilliance iCT Computed Tomography X-ray system by Philips Medical Systems Cleveland, citing A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1695-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Brilliance iCT Computed Tomography X-ray system
Reason
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Identifiers
| code_info | Model# 728306; Serial #'s: 85019 & 85023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1695-2015%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.