Company: MITSUBISHI HEAVY INDUSTRIES, LTD.Date of Enforcement Report: 9/24/2014 Class lI: PRODUCT VERO (TM) Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall Number Z-2653-2014 REASON Software Anomaly: Due...Read More

Company: Varian Medical Systems, Inc.Date of Enforcement Report: 9/24/2014 Class lI: PRODUCT 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall Number...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 9/24/2014 Class lI: PRODUCT Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. Recall Number Z-2665-2014 REASON Siemens Healthcare Diagnostics has identified a...Read More

Company: Dawning Technologies, IncDate of Enforcement Report: 9/24/2014 Class lI: PRODUCT ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient...Read More

Company: Biofire DefenseDate of Enforcement Report: 9/24/2014 Class lI: PRODUCT JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing...Read More