Siemens Medical Solutions USA, Inc recalls Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed fo…

Recall date

October 26, 2018

Source

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

Recall number

Z-0558-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Distribution to states of: AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, and UT.

Why it was recalled

This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of this product may have a potential impact on planned procedures as they may be delayed as well as in emergent cases, as clinical treatment may need to be terminated and transferred to a functioning 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

Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego 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.