Category: FDA Updates

FDA Updates

FDA Classifies Draeger VentStar Resus Neo Breathing Circuit Recall as Class I

Cracks in disposable infant breathing hoses could cause restricted ventilation, hypoxia, or death, prompting the agency's most serious recall designation.

FDA Updates

FDA Classifies GE HealthCare Patient Monitoring Software Correction as Class II Recall

The agency also clarified its description of the Portrait Core Services software issue, which can result in patients being removed from monitoring or alarm settings resetting during software updates.

FDA Updates

Medline Recalls Neonatal Breathing Circuits Due to Thermal Damage Risk

The nationwide recall affects Hudson RCI neonatal and infant heated wire breathing circuits following reports of melting, smoke, and localized thermal damage at the humidifier connector.

Clearances

FDA Clears PACS Viewer for Integrated EHR Imaging Workflows

The diagnostic imaging viewer enables clinicians to access and process medical images directly within the company's electronic health record platform, eliminating the need to switch between separate imaging and clinical systems.

Recalls

React Health Removes VOCSN V+Pro Ventilators

A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.