The Recall Desk

FDA (Devices) recall action 68932

Siemens Medical Solutions USA, Inc. recalled 2 products on 2014-10-08

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
2014-10-08
Critical
0
Units
1,087

Why these products were recalled

Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t

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)··2014-10-08

    Siemens Symbia Intevo SPECT/CT Systems Recalled for Rubber Isolator Aging

    Siemens Medical Solutions is recalling 48 Symbia Intevo SPECT/CT systems because a rubber isolator may degrade over time, potentially leading to drive belt rupture.

    Product
    The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. T
    Category
    Distribution
    40 states
  • ModerateFDA (Devices)··2014-10-08

    Siemens Symbia T Series Medical Imaging Systems Recalled for Rubber Isolator Defect

    Siemens is recalling 1,039 Symbia T Series SPECT/CT systems because a rubber isolator may degrade, potentially leading to drive belt rupture.

    Product
    The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose,
    Category
    Distribution
    40 states