The Recall Desk

FDA (Devices) recall action 76459

Siemens Medical Solutions USA, Inc recalled 6 products on 2017-03-15

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2017-03-15
Critical
0
Units
210

Why these products were recalled

Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.

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.

1–6 of 6

  • SevereFDA (Devices)··2017-03-15

    Siemens PRIMUS HI and Mevatron M2 Linear Accelerators Recalled for Weld Defect

    Siemens is recalling 35 PRIMUS HI and Mevatron M2 linear accelerators due to a defective weld seam that could cause overhead suspensions to fall and injure people.

    Product
    PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-03-15

    Siemens Medical Recalls 35 MEVATRON M 6700 Linear Accelerators

    Siemens Medical Solutions USA is recalling 35 MEVATRON M 6700 linear accelerators due to a defective weld seam that could cause the overhead suspension to fall and injure a patient or other person.

    Product
    MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-03-15

    Siemens Medical Linear Accelerators Recalled for Defective Weld Seams

    Siemens is recalling 35 MEVATRON M 6730/6740 linear accelerators because defective weld seams on overhead suspensions could break and fall, posing a risk of severe injury.

    Product
    MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-03-15

    Siemens MEVATRON M 7400/7440 Linear Accelerators Recalled for Defective Welds

    Siemens is recalling 35 MEVATRON M 7400/7440 linear accelerators because a defective weld seam could break, causing the overhead suspension to fall and potentially injure patients or others.

    Product
    MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-03-15

    Siemens Medical Linear Accelerators Recalled for Defective Overhead Suspension Welds

    Siemens is recalling 35 linear accelerator systems due to defective weld seams that could cause overhead suspensions to fall, posing a risk of severe injury.

    Product
    MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-03-15

    Siemens MEVATRON KD-2 Linear Accelerators Recalled for Defective Weld Seams

    Siemens is recalling 35 MEVATRON KD-2 linear accelerators due to defective weld seams that could break and cause the overhead suspension to fall, posing a risk of severe injury.

    Product
    MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Distribution
    0 states