The Recall Desk

FDA (Devices) recall action 79207

Siemens Medical Solutions USA, Inc recalled 2 products on 2018-03-07

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
2018-03-07
Critical
0
Units
7

Why these products were recalled

The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.

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

  • SevereFDA (Devices)··2018-03-07

    Siemens SOMATOM Go.Up CT Table Recall for Potential Instability

    Siemens Medical Solutions is recalling six SOMATOM Go.Up CT system tables because improperly tightened bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a t
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2018-03-07

    Siemens CT Table Recalled Due to Potential Bolt Loosening and Instability

    Siemens Medical Solutions is recalling SOMATOM Go.Now CT system tables because bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a
    Category
    Distribution
    4 states