Company:Viewray Incorporated Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-2085-2015 REASON ViewRay” received a report that the couch moved unexpectedly into the bore...Read More

Company:Elekta, Inc. Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-2063-2015 REASON A problem exists in...Read More