Recalls / —

—#144566

Product

Cios Alpha, mobile X-ray system

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 # 10308191

Why it was recalled

Software issues on Cios Alpha mobile C-Arm system

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

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

Timeline

Recall initiated

2016-02-19

Posted by FDA

2016-03-31

Terminated

2017-03-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #144566. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.