Recall Z-1958-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
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 patien
| Date | Jul 2, 2015 (initiated May 5, 2015) |
| Status | Terminated |
| Reason | under certain circumstances the Cios Alpha system may freeze during a procedure. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 37 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132094 | CIOS ALPHA Siemens Medi Cal Solutions, Inc., Mar 11, 2014 |