The Recall Desk

FDA (Devices) recall action 85448

Siemens Medical Solutions USA, Inc recalled 2 products on 2020-05-13

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
2020-05-13
Critical
0
Units
713

Why these products were recalled

It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.

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

  • HighFDA (Devices)··2020-05-13

    Siemens AXIOM Aristos FX Plus X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 399 AXIOM Aristos FX Plus x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdom
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-13

    Siemens AXIOM Aristos FX X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 314 AXIOM Aristos FX x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal colum
    Category
    Distribution
    0 states