Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 10/24/2018 Class II: PRODUCT Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Recall Number: Z-0170-2019 REASON The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The...Read More

FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices”, dated 10/17/18. This document contains some terms (e.g. Cybersecurity Bill of Material) and concepts (e.g., Tier 1 and Tier 2 risks) that is important for manufacturers to understand and address in premarket submissions. It also includes labeling recommendations for cybersecurity...Read More