—#137179

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K132094
Affected lot / code info: 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

Why it was recalled

under certain circumstances the Cios Alpha system may freeze during a procedure.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2015-05-05
Posted by FDA: 2015-07-02
Terminated: 2017-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137179. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.