The Recall Desk

FDA (Devices) recall action 81514

Siemens Medical Solutions USA, Inc recalled 3 products on 2018-11-21

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
2018-11-21
Critical
0
Units
83

Why these products were recalled

Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support

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

  • ModerateFDA (Devices)··2018-11-21

    Siemens Artis zee Biplane Systems Recalled for C-Arm Vibration Issues

    Siemens is recalling 14 Artis zee biplane systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.

    Product
    ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patien
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    0 states
  • ModerateFDA (Devices)··2018-11-21

    Siemens ARTIS Q Biplane Recalled for C-Arm Vibration Issues

    Siemens is recalling 54 ARTIS Q biplane x-ray systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.

    Product
    ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Pro
    Category
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    0 states
  • ModerateFDA (Devices)··2018-11-21

    Siemens Artis Q.zen Biplane X-Ray System Recalled for C-Arm Vibration

    Siemens Medical Solutions is recalling 15 Artis Q.zen biplane angiographic x-ray systems because C-arm vibrations may reduce image quality.

    Product
    ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Distribution
    0 states