Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/3/2019 Class II PRODUCT PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. Recall Number: Z-1892-2019 REASON There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy...Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2019 Class II PRODUCT Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored,...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.