The Recall Desk

FDA (Devices) recall action 94892

Siemens AG/Siemens Healthcare GmbH recalled 3 products on 2024-07-10

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
2024-07-10
Critical
0
Units
603

Why these products were recalled

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

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

1–3 of 3

  • HighFDA (Devices)··2024-07-10

    ARTIS Angiography Systems Recalled for Potential Radiation Overdose

    Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.

    Product
    ARTIS 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
    12 states
  • HighFDA (Devices)··2024-07-10

    Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose

    Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.

    Product
    ARTIS 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
    12 states
  • HighFDA (Devices)··2024-07-10

    Siemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses

    Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.

    Product
    ARTIS 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
    12 states