Siemens Medical Solutions USA, Inc recalls AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated an…

Recall date

January 5, 2018

Source

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

Recall number

Z-1150-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.

Why it was recalled

Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

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

What was recalled

AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.