The Recall Desk

FDA (Devices) recall action 66724

Siemens Medical Solutions USA, Inc recalled 2 products on 2013-12-11

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
2013-12-11
Critical
0
Units
29

Why these products were recalled

A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.

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

1–2 of 2

  • SevereFDA (Devices)··2013-12-11

    Siemens ARTISTE Linear Accelerator Recall for Dark Current Radiation Risk

    Siemens is recalling 26 ARTISTE Linear Accelerator systems due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic t
    Category
    Distribution
    7 states
  • SevereFDA (Devices)··2013-12-11

    Siemens Oncor Linear Accelerators Recalled for Dark Current Radiation Risk

    Siemens is recalling three Oncor Linear Accelerator units due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeuti
    Category
    Distribution
    7 states