Company:Siemens Medical Solutions USA, Inc..
Date of Enforcement Report 11/22/2017
Class lI:
PRODUCT
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. Serial Number: 2136, 2142
Recall Number Z-0093-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc.,Hoffman Estates, IL on 11/7/2017. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Worldwide Distribution to Malaysia, France, Japan, Reunion Island
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