The Recall Desk

FDA (Devices) recall action 85161

Siemens Medical Solutions USA, Inc recalled 4 products on 2020-04-15

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-04-15
Critical
0
Units
233,037

Why these products were recalled

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

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

1–4 of 4

  • SevereFDA (Devices)··2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Distribution
    35 states
  • SevereFDA (Devices)··2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Distribution
    35 states
  • SevereFDA (Devices)··2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Distribution
    35 states