King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety CommunicationFDA
FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety CommunicationFDA
FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural PacksFDA
The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.
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