Siemens Medical Solutions USA, Inc recalls Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures o…

Recall date

November 25, 2019

Source

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

Recall number

Z-0782-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

Why it was recalled

During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

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, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application