The Recall Desk

FDA (Devices) recall action 82730

Siemens Medical Solutions USA, Inc recalled 4 products on 2019-05-22

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2019-05-22
Critical
0
Units
—

Why these products were recalled

In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.

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

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2019-05-22

    Siemens Artis Zeego Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens is recalling 459 Artis Zeego angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.

    Product
    Artis Zeego (material 10280959) - Product Usage: AXIOM 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 tha
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2019-05-22

    Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens is recalling 459 Artis Q angiography systems because the floating tabletop may become blocked after a collision sensor activates.

    Product
    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM 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
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2019-05-22

    Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens Medical Solutions is recalling 459 Artis Q angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.

    Product
    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM 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
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2019-05-22

    Siemens Artis Zee Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens is recalling 459 Artis Zee angiography systems because the floating tabletop movement may be blocked after a collision sensor is activated.

    Product
    Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM 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 pati
    Category
    Distribution
    33 states