Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0093-2018)

Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System 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 588keV. 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 588keV. 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 place taken at different angles or spiral planes taken at different angles.SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. These systems are intended to be utilized 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.

Class II

The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.

Serial Number: 2136, 2142

Worldwide Distribution to Malaysia, France, Japan, Reunion Island

Voluntary: Firm initiated