The Recall Desk

FDA (Devices) recall action 76016

Siemens Medical Solutions USA, Inc recalled 2 products on 2017-01-18

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
2017-01-18
Critical
0
Units
3,000

Why these products were recalled

Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.

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.

1–2 of 2

  • ModerateFDA (Devices)··2017-01-18

    Siemens Artis zee/zeego Angiographic X-ray System Recall for Generator Defects

    Siemens is recalling Artis zee/zeego angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.

    Product
    Artis zee/zeego, Angiographic x-ray system Stand alone system 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. Procedure
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-01-18

    Siemens Recalls Artis Q Angiographic X-Ray Systems for Generator Defects

    Siemens is recalling Artis Q angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.

    Product
    Artis Q/Q.zen, Angiographic x-ray system Stand alone system 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