The Recall Desk

FDA (Devices) recall action 69114

Siemens Medical Solutions USA, Inc. recalled 3 products on 2015-01-14

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2015-01-14
Critical
0
Units
2,213

Why these products were recalled

Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.

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.

1–3 of 3

  • HighFDA (Devices)··2015-01-14

    Siemens Symbia S Series Medical Imaging Systems Recalled for Detector Motion

    Siemens is recalling 877 Symbia S series imaging systems due to reports of unintended detector motion that may cause patient compression injuries.

    Product
    The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-01-14

    Siemens Symbia T Series SPECT/CT Systems Recalled for Detector Motion

    Siemens Medical Solutions USA is recalling 1,330 Symbia T series SPECT/CT systems worldwide due to reports of unintended radial detector motion that may cause patient compression injuries.

    Product
    The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-01-14

    Siemens Symbia Intevo SPECT CT Systems Recalled for Detector Motion

    Siemens is recalling six Symbia Intevo SPECT CT systems worldwide because unintended detector motion may cause patient compression injuries.

    Product
    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration…
    Category
    Distribution
    0 states