The Recall Desk

FDA (Devices) recall action 83081

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
116

Why these products were recalled

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

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 Scanner Recalled for Performance Issues

    Siemens Medical Solutions is recalling nine SOMATOM go.Up CT scanners due to sporadic performance problems that may interrupt scanning workflows and delay patient diagnosis.

    Product
    SOMATOM go.Up (Model #11061610) 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 images…
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens SOMATOM go.Now CT Scanner Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling 53 SOMATOM go.Now CT scanners due to potential sporadic performance problems that may cause scanning workflow interruptions and delays in diagnosis.

    Product
    SOMATOM go.Now (Model #11061620), 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 images…
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens SOMATOM go.All CT Systems Recalled for Performance Issues

    Siemens is recalling 24 SOMATOM go.All CT systems due to sporadic performance problems that may interrupt scanning workflows and delay diagnoses.

    Product
    SOMATOM go.All (Model #11061630), 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 images…
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens SOMATOM go.Top CT Systems Recalled for Performance Issues

    Siemens Medical Solutions is recalling 30 SOMATOM go.Top CT systems due to potential performance problems that may interrupt scanning workflows and delay patient diagnoses.

    Product
    SOMATOM go.Top (Model #1161640), 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 images…
    Category
    Distribution
    33 states