Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Radiation Therapy Treatment Planning System, Model 5.0 Recall Number Z-0079-2017 REASON For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only...Read More

Company: Medtronic Navigation Inc. Date of Enforcement Report 10/12/2016 Class lI: PRODUCT Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 10/19/2016 Class lI: PRODUCT Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities Recall Number Z-0073-2017 REASON Image data for a patients image may not be...Read More