The Recall Desk

FDA (Devices) recall action 80735

Siemens Medical Solutions USA, Inc recalled 2 products on 2018-08-29

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
2018-08-29
Critical
0
Units
1,366

Why these products were recalled

In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock and this could lead to overloading the safety rope which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down during patient positioning. Patients and users may be seriously injured.

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)··2018-08-29

    Siemens 3D TOP Ceiling Stand Recalled for Potential Rope Failure

    Siemens Medical Solutions is recalling 699 3D TOP Ceiling Stands because a load-bearing rope could break, causing the arm to drop and potentially seriously injure patients or users.

    Product
    3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2018-08-29

    Siemens 3D V Ceiling Stand Recalled for Potential Rope Failure

    Siemens is recalling 3D V ceiling stands because the primary load-bearing rope could break, causing the arm to drop and potentially seriously injuring patients or users.

    Product
    3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The c
    Category
    Distribution
    3 states