FDA Device recall Z-0782-2020
Cios Alpha, Model Number 10308191
- FDA Device
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Cios Alpha, Model Number 10308191 by Siemens Medical Solutions Usa, citing during a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0782-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-25 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Reason
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
Identifiers
| code_info | Serial Numbers: 11294 11202 12009 11141 11163 11032 11311 11260 11258 12530 12334 11376 12426 11336 11132…Serial Numbers: 11294 11202 12009 11141 11163 11032 11311 11260 11258 12530 12334 11376 12426 11336 11132 11295 11044 11005 11333 11386 12597 10076 12677 10115 11291 12523 11056 12319 12623 12512 12574 12647 12014 12452 12306 12317 11119 12576 12678 12513 12335 12490 12657 11200 11281 11283 12425 12023 12396 11285 11205 11103 11105 11257 11074 12379 11013 10021 11330 11066 10057 11143 11077 11319 11240 11349 11098 12339 11153 11372 10037 11328 12529 12308 10063 11106 12373 12584 11067 10082 12026 12027 11168 12492 10019 11317 10035 11198 12040 12307 12440 11165 12611 11094 11226 11370 12377 11348 11009 11018 10058 12321 12004 11378 11167 11248 11306 11229 12028 11144 12313 11287 12654 12043 11038 12320 12514 11352 12612 11316 11243 11314 12626 11374 11162 11292 12394 12498 12549 11120 11134 12494 12526 12528 11219 11220 11346 12318 12562 12607 1264 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0782-2020%22
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