Company: Elekta, Inc.. Date of Enforcement Report 11/26/2014 Class lI: PRODUCT MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0221-2015 REASON A problem can exist...Read More

Company: Accuray Incorporated Date of Enforcement Report 11/26/2014 Class lI: PRODUCT CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-0218-2015...Read More