The Recall Desk

FDA (Devices) recall action 72091

Siemens Medical Solutions USA, Inc recalled 3 products on 2015-10-14

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
2015-10-14
Critical
0
Units
339

Why these products were recalled

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

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)··2015-10-14

    Siemens SOMATOM Definition Edge CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition Edge; 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)··2015-10-14

    Siemens SOMATOM Definition AS CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition AS CT scanners to fix a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition AS, 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)··2015-10-14

    Siemens SOMATOM Definition Flash CT Scanner Software Recall

    Siemens Medical Solutions USA is recalling 113 SOMATOM Definition Flash CT scanners due to a software bug in version VA48A_SP0 that affects visual warnings and image quality.

    Product
    SOMATOM Definition Flash; 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