Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010

Philips Healthcare is recalling the company’s Avalon fetal monitors because of an increase in inaccurate readings. As a result, users may fail to identify fetal distress, fail to perform needed interventions, or perform unnecessary interventions such as cesarean delivery. All of these could result in serious injury or death to the mother and fetus.

Increased inaccuracies have included switching between the fetal and maternal heart rates, doubling or halving of the fetal heart rate, false decelerations, a mismatch between the audible and printed readings, and noisy or erratic signals.

The affected models are the FM20, FM30, FM40 and FM50. Philips is not removing them from the market at this time. While the company continues to investigate this situation, it recommends several interim steps to reduce the likelihood of inaccurate readings or their impact.

These include using the monitor’s cross-channel verification feature to differentiate between the fetal and maternal heart rates, and, when in doubt, confirming the fetal heart rate with ultrasound imaging or fetal scalp electrodes.

The company also recommends that users recognize situations that can increase the likelihood of inaccurate readings. These include contractions, maternal tachycardia, fetal or maternal movement, and maternal pushing, coughing or vomiting.