FDA Device recall Z-1958-2015
Cios Alpha
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Cios Alpha by Siemens Medical Solutions Usa, citing under certain circumstances the Cios Alpha system may freeze during a procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1958-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-05 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Reason
under certain circumstances the Cios Alpha system may freeze during a procedure.
Identifiers
| code_info | Model Number of device 10308191, serial numbers: 11032 11044 11005 10115 11056 10057 10076 10019 10021 10035…Model Number of device 10308191, serial numbers: 11032 11044 11005 10115 11056 10057 10076 10019 10021 10035 10037 10073 11074 11075 11077 11083 10078 11066 11067 11013 10063 10082 11094 10089 11080 11009 11018 11082 10058 10098 11015 11016 11038 10096 10116 11035 11064 |
|---|
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-1958-2015%22
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