Boston Business Journal - by Julie M. Donnelly
Philips Healthcare is voluntarily recalling its Avalon Fetal Monitors because of complaints concerning inaccurate fetal heart-rate readings during ultrasound procedures.
The company noted that while the complaints reflect known limitations of fetal monitors, the number of complaints is higher than with prior generations of monitors.
Philips said it does not believe care providers need to stop using the monitors completely, but the letter says federal regulators asked Philips to issue a voluntary recall of the product.
Netherlands-based Philips Healthcare, whose U.S. operations are headquartered in Andover, Mass., warned that incorrect readings could lead to unnecessary interventions including cesarean sections. Alternately, inaccurate heart rate readings could cause health care providers to miss signs of fetal distress.
The recall was detailed in a letter to health care providers released by the U.S. Food and Drug Administration. The models affected by the recall are the FM20, FM30, FM40, and FM50 versions of the Philips Avalon Fetal Monitor.
The letter gave instructions for health care providers to minimize the potential for inaccurate readings.