Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention…

Recall date

June 26, 2024

Source

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

Recall number

Z-2240-2024

FDA classification

Class II

Brand / firm

Siemens AG/Siemens Healthcare GmbH

Sold / distributed

Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.

Why it was recalled

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

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 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.