Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall Number Z-0867-2013 REASON Varian has identified an anomaly with the Eclipse...Read More

Company:Elekta, Inc. Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Monaco RTP System. Radiation treatment planning. Recall Number Z-0841-2013 REASON The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta, GA,I on 2/11/2013. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More