FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 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-1295-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 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
- 2019-03-22
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
- Root cause
- Device Design
- Action
- Siemens issued Customer Safety Advisory Letter dated 3/22/19 advising of problem, health risk and action to take: recommends to avoid overwriting the organ programs, as this can lead to frequent operations. Siemens is distributing this letter and the addendum to the user manual to all potentially affected users Contact our service organization for any additional questions at 1-800-888-7436.
- Quantity
- 2 US
- Distribution
- US Nationwide Distribution in the states of NC, MA
- Lot, serial or model codes
- Cios Alpha system with SW VA30
- 510(k) numbers
- ["K181560"]
- 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