Z-1295-2019Class II

Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200

Name: Z-1295-2019 Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-03-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-03-22 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2019-03-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1295-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-22
Posted: 2019-05-07
Terminated: 2020-05-12
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
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: design
FDA 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 in commerce: 2 US
Distribution: US Nationwide Distribution in the states of NC, MA
Product codes and lots: Cios Alpha system with SW VA30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1295-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-07

Product code OWB

K181560Class IICios AlphaSiemens Medical Systems USA, Inc. / cleared 2018-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)