Siemens Medical Solutions USA, Inc recalls Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha an…

Recall date

April 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2127-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.

Why it was recalled

The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.