Recalls / —
—#144441
Product
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, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
- FDA product code
- OWB — Interventional Fluoroscopic X-Ray System
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K132094
- Affected lot / code info
- Model Number: 10308191
Why it was recalled
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 (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- US Nationwide Distributed in the states of AR, CA, NE and UT
Timeline
- Recall initiated
- 2016-02-16
- Terminated
- 2017-11-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144441. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.