Tag: medical device safety
FDA Issues Early Alert for Baxter Volara Breathing Device Air Leaks
FDA issues early safety alert for Baxter Volara breathing device circuits that may leak air and medication during therapy. Healthcare…
FDA Issues 47 Medical Device Safety Alerts in 2024, Highlighting Critical Patient Safety Risks
The FDA issued 47 medical device safety communications in 2024, demonstrating enhanced post-market surveillance capabilities. These alerts cover critical care…
FDA Issues Early Alert for GE HealthCare Infant Resuscitation System Safety Issue
FDA issues early alert for GE HealthCare infant resuscitation systems due to air-oxygen blender knob shaft loosening that may affect…
FDA Issues Early Alert for Abiomed Catheter Kit Linked to Blood Clot Formation
FDA warns that prolonged use of Abiomed 14Fr Low Profile Introducer catheter may cause blood clot formation. Healthcare providers advised…
FDA Issues Early Alert for Heart Pump Controller Software Error That May Cause Dangerous Restarts
FDA issues early alert for critical software error in Automated Impella Controller that may cause dangerous restarts during life-sustaining cardiac…
FDA Issues Class I Recall for VOCSN V+Pro Ventilators Over Critical Oxygen Leak Risk
FDA announces Class I recall of VOCSN V+Pro ventilators due to manufacturing defect causing undetected oxygen leaks. React Health removes…
FDA Issues Correction Notice for TRUE METRIX Blood Glucose Monitors Over Error Code Risk
Trividia Health has issued a correction notice for TRUE METRIX blood glucose monitors after reports of an E-5 error code…