Z-1278-2016Class II

Cios Alpha, mobile X-ray system

Name: Z-1278-2016 Cios Alpha, mobile X-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-19 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cios Alpha, mobile X-ray system on 2016-02-19. FDA classified it as Class II and gives the reason as "Software issues on Cios Alpha mobile C-Arm system". 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-1278-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-19
Posted: 2016-03-31
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Cios Alpha, mobile X-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Software issues on Cios Alpha mobile C-Arm system
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Siemens sent an Customer Safety Advisory Notice on February 26, 2016, to inform them of some issues that may arise on the Cios Alpha unit. The letter identified the product the problem and the action needed to be taken by the customer. Users were instructed to change the date format to DDMMYYYY to prevent issues, not to release radiation as long as the DVD icon is blinking and to disconnect and re-connect the trolley if the system is needed immediately. In the meantime they are preparing a modification of Cios Alpha that will resolve the above-mentioned issues. As soon as the modification is available, a service engineer will get in touch with each customer and implement the modification to the Cios Alpha system free of charge. If the device was sold, customers were instructed to forward the recall notification to the new owner. For further questions please call (610) 448-6478.
Quantity in commerce: 89 systems
Distribution: Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
Product codes and lots: Model # 10308191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1278-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1278-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

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)