The Recall Desk

FDA (Devices) recall action 66778

Siemens Medical Solutions USA, Inc. recalled 2 products on 2014-10-29

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
2014-10-29
Critical
0
Units
5,424

Why these products were recalled

Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.

Reports of loose bolts in the detector support structure of Symbia and e.cam systems.

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

  • HighFDA (Devices)··2014-10-29

    Siemens Symbia E SPECT Systems Recalled for Loose Bolts in Detector Support

    Siemens Medical Solutions is recalling 562 Symbia E SPECT systems due to reports of loose bolts in the detector support structure.

    Product
    Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Distribution
    53 states
  • HighFDA (Devices)··2014-10-29

    Siemens e.cam Gamma Camera Systems Recalled for Loose Bolts

    Siemens Medical Solutions is recalling e.cam gamma camera systems due to reports of loose bolts in the detector support structure.

    Product
    e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Distribution
    53 states