Recall Z-1281-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: 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, cardi
| Date | Feb 16, 2016 |
| Status | Terminated |
| Reason | Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a Customer Safety Advisory Notice dated February 18, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Siemens is planning to replace the affected parts as a precautionary measure. A Siemens service engineer will contact each customer to schedule implementation of this precautionary measure. |
| Quantity | 4 units |
| Distribution | US Nationwide Distributed in the states of AR, CA, NE and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132094 | CIOS ALPHA Siemens Medi Cal Solutions, Inc., Mar 11, 2014 |