The Recall Desk

FDA (Devices) recall action 83112

Siemens Medical Solutions USA, Inc recalled 4 products on 2019-07-10

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
2019-07-10
Critical
0
Units
276

Why these products were recalled

The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.

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

  • ModerateFDA (Devices)··2019-07-10

    Siemens SOMATOM go.Up CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Up CT systems due to sporadic performance problems that may cause diagnostic delays or patient rescans.

    Product
    SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens SOMATOM go.Now CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for patient rescans.

    Product
    SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens SOMATOM go.All CT Scanner Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.All CT scanners due to potential performance problems that may cause diagnostic delays or require patient rescans.

    Product
    SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
    Category
    Distribution
    26 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens CT System Recalled for Potential Scanning Workflow Interruptions

    Siemens Medical Solutions is recalling 69 SOMATOM go.Top CT systems due to potential sporadic performance problems that may cause diagnostic delays or the need for patient rescans.

    Product
    SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
    Category
    Distribution
    26 states