The Recall Desk

FDA (Devices) recall action 80047

Siemens Medical Solutions USA, Inc recalled 2 products on 2018-06-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-06-06
Critical
0
Units
37

Why these products were recalled

There is a potential for a software issue that may cause the need for necessary patient rescans.

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

1–2 of 2

  • ModerateFDA (Devices)··2018-06-06

    Siemens SOMATOM Go.Up CT Scanner Recalled for Software Issue

    Siemens is recalling 33 SOMATOM Go.Up CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2018-06-06

    Siemens SOMATOM go.Now CT Scanner Software Recall

    Siemens Medical Solutions is recalling 4 SOMATOM go.Now CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Distribution
    18 states