Reported Apr 6, 2016 · Terminated
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated…
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?
- AXIOM Artis zee/zeego, system, x-ray
- angiographic Product UsageAXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
- Lot codes and dates
- Serial Numbers
61 of 61 codes
Artis Q biplane Serial # 121061121089121094121006121013121040121062121082121011121039121134121053121054121014121112121051121004121133121018121036121137121012121049121078121019121010121139121081121096121015121115121016121138121020121140121106121120121122121121121109121144121047121088121027121136121141121069121009121057121056121034121008121058121085121071121023121079121041121037121046
- Serial Numbers
- Amount recalled
- 986 systems in total
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
This product could cause temporary or reversible health problems — stop using it.
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