Company: GE Healthcare LLC Date of Enforcement Report: 2/26/2014 Class lI: PRODUCT GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means...Read More

Company:Elekta, Inc.Date of Enforcement Report:2/26/2014 Class lI: PRODUCT Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs – (1) You do an online VolumeView acquisition and registration. (2) You accept the...Read More