Z-1281-2016Class II

CIOS ALPHA (Image-intensified fluoroscope x-ray system)

Name: Z-1281-2016 CIOS ALPHA (Image-intensified fluoroscope x-ray system)
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2016-02-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1281-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-16
Posted: 2016-03-31
Terminated: 2017-11-08
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 4 units
Distribution: US Nationwide Distributed in the states of AR, CA, NE and UT
Product codes and lots: Model Number: 10308191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2016	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)