Siemens Medical Solutions USA, Inc. recalls The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatom…

Recall date

August 12, 2014

Source

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

Recall number

Z-0913-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution - USA (naitonwide) and Internationally to Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India…

Why it was 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.

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

What was recalled

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 and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia 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 limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. 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 5S8keV. CT: The CT component is intended to produce cross-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. 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 patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.