Tag: FDA alert

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 Early Alert on Draeger Anesthesia Machine Ventilator Failures

The FDA has issued an early alert on Draeger anesthesia workstations with a manufacturing defect that may cause ventilator failure…

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…