Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Cios Alpha, mobile X-ray system

FDA Recall Z-1278-2016 · Posted 2016-03-31

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-02-19
Date Terminated2017-03-20
Product Quantity89 systems

Reason for Recall

Software issues on Cios Alpha mobile C-Arm system

Firm 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.

Root Cause

Software in the Use Environment

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑