FDA Device recall Z-1004-2017
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstr…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstr… by Philips Medical Systems Cleveland, citing failure to correctly document the installation of four M12 Bolts into the system rotor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1004-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-25 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Reason
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Identifiers
| code_info | Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26 |
|---|
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-1004-2017%22
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