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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

Recalled December 12, 2018 · FDA recall Z-0558-2019 · Siemens Medical Solutions USA

Hazard
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. · FDA Class II
Units
64 (16 in US)
Sold at
US Distribution to states of: AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, and UT.

Description

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.

Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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 | RecallWatchUSA