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Philips Fetal Monitors Safety Alert

by Lynn Shapiro, Writer | September 09, 2009
Avalon FM20 and FM30
are among the fetal monitor
technologies that are subject
to a safety alert
Avalon Fetal Monitors Subject of Safety Alert

Having received a number of complaints about inaccurate readings when using some Philips Avalon fetal monitors, the FDA has issued a MedWatch and "Dear Health Care 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 said in a statement. Adverse events related to the product should be reported to the FDA's MedWatch Adverse Event Reporting program.

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Get links to all the details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181505.htm