Reported Dec 12, 2018 · Terminated
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- 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.
- Lot codes and dates
- Serial nos
910045-09911354-02910045-19908883-23910045-15910045-14910045-25908883-04911354-25908883-18908883-11910045-21911354-26908883-06908883-02911354-27
- Serial nos
- Amount recalled
- 64 (16 in US)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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