Philips Avalon Fetal Monitor FM20,FM30, FM40, FM 50

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. The complaints most commonly occur during the second stage of labor. Recognizing these conditions and responding appropriately is important to avoiding serious adverse health consequences.



Date Posted June 26, 2009
Recall Number Z-1478-2009
Product Philips Avalon Fetal Monitor FM20; Model Number: M2702A.
Code Information Units with serial numbers in the range of DE53001002 through DE53107383.

Recalling Firm/
Manufacturer Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Reason for
Recall Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions
Action Philips Healthcare issued an "Urgent-Medical Device Correction" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade. Questions can be made to Philips response center at 1-800-722-9377.
Quantity in Commerce 5,663 units
Distribution Worldwide Distribution