Siemens Medical Solutions USA, Inc recalls Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

Recall date

June 6, 2019

Source

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

Recall number

Z-1904-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide

Why it was recalled

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

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

What was recalled

Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355