Siemens Medical Solutions USA, Inc recalls Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for si…

Recall date

May 25, 2018

Source

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

Recall number

Z-2526-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

HI , IL, MI, NC, NY, VA, WI

Why it was recalled

Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure

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 zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.