FDAnews
www.fdanews.com/articles/120271-avalon-fetal-monitors-subject-of-safety-alert

Avalon Fetal Monitors Subject of Safety Alert

September 8, 2009
Having received a number of complaints about inaccurate readings when using some Philips Avalon fetal monitors, the FDA has issued a MedWatch and “dear healthcare provider” letter about Models FM20, FM30, FM40 and FM50 with the ultrasound transducer. Philips issued its own safety alert as inaccurate output readings could lead to unnecessary interventions, failure to identify the need for interventions and failure to identify fetal distress, the FDA says in a statement. Adverse events related to the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.