The Recall Desk

FDA (Devices) recall action 71867

Siemens Medical Solutions USA, Inc. recalled 3 products on 2015-08-26

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
2015-08-26
Critical
0
Units
3,068

Why these products were recalled

Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

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

1–3 of 3

  • SevereFDA (Devices)··2015-08-26

    Siemens Intevo Series Imaging Systems Recalled for Overheating Risk

    Siemens Medical Solutions USA is recalling 185 Intevo Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.

    Product
    Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2015-08-26

    Siemens Symbia T Series Imaging Systems Recalled for Overheating Risk

    Siemens Medical Solutions is recalling Symbia T Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.

    Product
    Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2015-08-26

    Siemens Symbia S Series Nuclear Medicine Imaging Systems Recalled for Overheating Risk

    Siemens is recalling Symbia S Series nuclear medicine imaging systems because improper fuses could cause the Power Controller assembly to overheat.

    Product
    Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.
    Category
    Distribution
    51 states