The Recall Desk

FDA (Devices) recall action 70246

Siemens Medical Solutions USA, Inc. recalled 2 products on 2015-03-25

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
2015-03-25
Critical
0
Units
5,275

Why these products were recalled

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

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)··2015-03-25

    Siemens E.CAM Systems Recalled for Incorrectly Assembled Radial Motor Drives

    Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.

    Product
    E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Distribution
    48 states
  • ModerateFDA (Devices)··2015-03-25

    Siemens Symbia E SPECT Systems Recalled for Incorrect Radial Motor Assembly

    Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.

    Product
    Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Distribution
    48 states