The Recall Desk

FDA (Devices) recall action 75606

Siemens Medical Solutions USA, Inc recalled 3 products on 2016-11-23

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
2016-11-23
Critical
0
Units
13,971

Why these products were recalled

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

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.

1–3 of 3

  • HighFDA (Devices)··2016-11-23

    Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems 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 patients. Procedures
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-11-23

    Siemens AXIOM Artis Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling AXIOM Artis angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems 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 patients. Procedures tha
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-11-23

    Siemens Artis Q Angiographic X-ray System Recalled for Footswitch Defect

    Siemens is recalling 4,657 Artis Q angiographic x-ray systems because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times.

    Product
    Artis Q, Angiographic x-ray system Product Usage: The Artis systems 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 patients. Procedures that can
    Category
    Distribution
    0 states