The Recall Desk

FDA (Devices) recall action 75812

Siemens Medical Solutions USA, Inc recalled 3 products on 2016-12-21

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-12-21
Critical
0
Units
312

Why these products were recalled

Software update that provides software and firmware bug-fixes to improve system performance

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.

1–3 of 3

  • ModerateFDA (Devices)··2016-12-21

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update

    Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Distribution
    0 states