The Recall Desk

FDA (Devices) recall action 76454

Siemens Medical Solutions USA, Inc recalled 4 products on 2017-02-22

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
2017-02-22
Critical
0
Units
776

Why these products were recalled

Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

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.

1–4 of 4

  • HighFDA (Devices)··2017-02-22

    Siemens Recalls ONCOR Radiation Therapy Systems Due to Collimator and Weld Defects

    Siemens is recalling 194 ONCOR radiation therapy systems in the US due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cance
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Siemens Oncor Avant-garde Radiation Therapy Systems Recalled for Sensor Defects

    Siemens is recalling 194 Oncor Avant-garde radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: 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)··2017-02-22

    Siemens PRIMUS Radiation Therapy Systems Recalled for Collimator and Weld Defects

    Siemens is recalling 194 PRIMUS radiation therapy systems due to incorrect collimator position displays and improper weld seams at the overhead suspension.

    Product
    PRIMUS Medical charged-particle radiation therapy system Product Usage: 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
  • HighFDA (Devices)··2017-02-22

    Siemens ARTISTE MV System Recalled for Collimator and Weld Defects

    Siemens is recalling 194 ARTISTE MV radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: 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