Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/23/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional,...Read More
Company: Medtronic Inc. Cardiac Rhythm Disease Management Date of Enforcement Report 9/23/2015 Class lI: PRODUCT Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. Recall Number Z-2777-2015 REASON Medtronic has identified an issue with a USB memory component contained within a subset of CryoConsoles. The issue can result in extended...Read More
The U.S. FBI issued a Public Service Announcement on the Internet of Things that includes, “Criminals can also gain access to unprotected devices used in home health care, such as those used to collect and transmit personal monitoring data or time-dispense medicines. Once criminals have breached such devices, they have access to any personal or...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 email@example.com for more info.