The Recall Desk

FDA (Devices) recall action 74716

Siemens Medical Solutions USA, Inc recalled 3 products on 2016-08-17

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-08-17
Critical
0
Units
—

Why these products were recalled

The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2016-08-17

    Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Contamination

    Siemens is recalling AXIOM Artis angiography systems because biomass contaminants in the cooling system may damage the pump.

    Product
    ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Distribution
    52 states
  • ModerateFDA (Devices)··2016-08-17

    Siemens Medical Solutions Recalls Artis Q and Q.Zen Angiography Systems

    Siemens Medical Solutions is recalling Artis Q and Q.Zen angiography systems because biomass in the cooling system may damage the pump.

    Product
    ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures…
    Category
    Distribution
    52 states
  • ModerateFDA (Devices)··2016-08-17

    Siemens AXIOM Artis Angiography Systems Recalled for Cooling System Contamination

    Siemens is recalling AXIOM Artis angiography systems because biomass contamination in the cooling system may damage the pump.

    Product
    AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to…
    Category
    Distribution
    52 states