The Food & Drug Administration prompted Philips Healthcare (AEX:PHI) to issue a voluntary recall notice on four models of its Avalon fetal monitor after receiving complaints that the devices were providing inaccurate readings.
The Dutch company, which houses its U.S. headquarters in Andover, Mass., received numerous complaints about Avalon monitor models FM20, FM30, FM40 and FM50.
Philips did not believe a recall was necessary, but the federal watchdog agency compelled it to provide further instructions on how to use the devices properly and issued a voluntary recall notice (PDF) in the January edition of Patient Safety News, which is sent out to healthcare providers.
Problems with inaccurate readings on the monitors could lead to unnecessary Caesarean deliveries and failure to identify the need for intervention or fetal distress, according to the agency.
The problem was originally reported in a Sept. 4, 2009, device safety alert.