Z-1958-2015Class II

Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical...

Name: Z-1958-2015 Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-05-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-05-05 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications... on 2015-05-05. FDA classified it as Class II and gives the reason as "under certain circumstances the Cios Alpha system may freeze during a procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1958-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-05
Posted: 2015-07-02
Terminated: 2017-01-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Cios Alpha; 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: under certain circumstances the Cios Alpha system may freeze during a procedure.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Safety Advisory Notice dated May 5 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were alerting them about the issue and risks involved. Customers were provided work-around instructions until a software fix is released. For further questions please call (610) 219-6300.
Quantity in commerce: 37
Distribution: Nationwide Distribution
Product codes and lots: Model Number of device 10308191, serial numbers: 11032 11044 11005 10115 11056 10057 10076 10019 10021 10035 10037 10073 11074 11075 11077 11083 10078 11066 11067 11013 10063 10082 11094 10089 11080 11009 11018 11082 10058 10098 11015 11016 11038 10096 10116 11035 11064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1958-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1958-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code OWB

K132094Class IICios AlphaSiemens Medi Cal Solutions, Inc. / cleared 2014-03-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)