Siemens Medical Solutions USA, Inc recalls ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Recall date

May 30, 2018

Source

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

Recall number

Z-2524-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.

Why it was recalled

During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

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

What was recalled

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000