FDA Device recall Z-2175-2018
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240 by Philips Medical Systems Cleveland, citing the patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2175-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-30 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | CA, MD, NV, OH, TX, WI |
Product
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Reason
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Identifiers
| code_info | System Serial Numbers: 6147, 6143 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Philips Medical Systems Cleveland recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2175-2018%22
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