Siemens Medical Solutions USA, Inc. recalls Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the…

Recall date

August 16, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0061-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwa…

Why it was recalled

The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Symbia S, Product Usage 1) SPECT: 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. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy. .