The Recall Desk

FDA (Devices) recall action 82227

Siemens Medical Solutions USA, Inc recalled 4 products on 2019-05-08

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
2019-05-08
Critical
0
Units
212

Why these products were recalled

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

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)··2019-05-08

    Siemens CT Scanners Recalled for Dual Energy Scan Abortion Risk

    Siemens is recalling 53 SOMATOM Definition AS CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray trans
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode

    Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-08

    Siemens CT Scanner Recall Due to Software Issue in Dual Spiral Mode

    Siemens is recalling 53 SOMATOM Confidence CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode

    Siemens is recalling 53 SOMATOM Edge Plus CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Distribution
    0 states