Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351 — Class II medical device recall Z-2174-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-06-20, distributed in CA, MD, NV, OH, TX, WI. The patient support head holder could contact the back ISO shelter wall during manual or motorized motion thro
| Recall number | Z-2174-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-06-12 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-04-14 |
| Distributed | CA, MD, NV, OH, TX, WI |
| Countries outside the US | AF, CA, DE, IQ, IT, KR, KW, LB |
| Quantity | 3 |
| Serial numbers | 10605, 10708, 9208 |
| Model numbers | 728231 |
Product
Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2174-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.