FDA Medical Device Recalls (openFDA)
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, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
- Recall number
- Z-1281-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-02-16
- Posted
- not on file
- Terminated
- 2017-11-08
- 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
- Lot, serial or model codes
- Model Number: 10308191
- 510(k) numbers
- ["K132094"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28