Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator’s Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. Recall Number...Read More

Company:RAYSEARCH LABORATORIES AB.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1806-2014 REASON This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid...Read More

Company:Elekta, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT Synergy XVI Intended for radiation therapy treatment. Recall Number Z-1724-2014 REASON XVI can incorrectly calculate the target position of the treatment table.. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta GA. on 4/23/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 380 US DISTRIBUTION Nationwide and Internationally...Read More

Company:Elekta, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT 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. Z-1800-2014. REASON When using CMA, if the user hovers the mouse pointer exactly above...Read More

Company:Elekta, Inc.Date of Enforcement Report:6/25/2014 Class lI: PRODUCT iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. Recall Number Z-1807-2014 REASON A bug in the software prevents the iGUIDE software from logging off. RECALLING FIRM/MANUFACTURER...Read More