Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of pa
FDA device recall Z-1958-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- under certain circumstances the Cios Alpha system may freeze during a procedure.
- Action taken
- Siemens sent an Safety Advisory Notice dated May 5 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were alerting them about the issue and risks involved. Customers were provided work-around instructions until a software fix is released. For further questions please call (610) 219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 37
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-05-05
- Date posted
- 2015-07-02
- Date terminated
- 2017-01-13
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIOS ALPHA (K132094) | Siemens Medi Cal Solutions, Inc. | 2014-03-11 |