Philips Avalon Fetal Monitors
MedSun: Newsletter #40, September 2009
FDA MedWatch Safety Alert
FDA issued a Dear Healthcare Provider Letter to notify healthcare professionals and facilities of a number of complaints of inaccurate readings when using the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40, and FM50 with the ultrasound transducer. On September 4, 2009, Philips issued an Important Device Safety Alert. Inaccurate output readings, if not properly addressed, may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress.
FDA MedWatch Safety Alert. Philips Avalon Fetal Monitors. September 4, 2009.
FDA Dear Healthcare Provider Letter. Philips Avalon Fetal Monitors. September 4, 2009.
Philip’s Healthcare’s Important Device Safety Alert