The Recall Desk

FDA (Devices) recall action 73589

Siemens Medical Solutions USA, Inc recalled 2 products on 2016-04-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-04-06
Critical
0
Units
3,514

Why these products were recalled

Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2016-04-06

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

    Siemens is recalling 1,757 AXIOM Artis angiography systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscop
    Category
    Distribution
    50 states
  • ModerateFDA (Devices)··2016-04-06

    Siemens Artis zee/zeego X-Ray Systems Recalled for Cooling System Leak

    Siemens is recalling 1,757 Artis zee/zeego angiographic X-ray systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoro
    Category
    Distribution
    50 states