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,...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 6, 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: 2141,...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Recall Number Z-0102-2018 REASON An undetected shift between the information displayed in the navigation software and the actual...Read More

Company:ICU Medical IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT Plum 360 Infusion System, List number 30010. Recall Number Z-0101-2018 REASON (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the “Paused” state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be...Read More