Infant Apnea Monitors Recalled, May Fail to Sound Alarm

Nearly 5,000 infant apnea monitors made by Respironics Inc. are being recalled because the devices may fail to sound an alarm during periods of stopped breathing or low heart rate, the Food and Drug Administration said.

The SmartMonitor 2 Infant Apnea Monitor, models 4002 and 4003 with the serial numbers 3000033364 through 3000038740, are included in the FDA Class I recall. The products were made and distributed between Jan. 16, 2008 and November 13, 2008.

The SmartMonitor devices are used in hospitals and in homes to monitor the breathing and heart rates of babies who may suffer from a condition called apnea during which breathing stops. They are designed to sound a loud alarm to warn medical professionals or parents of the condition.

However, the FDA said some of the units have failed to sound that alarm when needed. Children who stop breathing for even a short amount of time may die or suffer severe brain damage. Class 1 recalls are the most serious type of FDA recall and are issued in situations where there is a reasonable probability that use of these products will cause serious injury or death.

Respironics, Inc. is based in Murrysville, Penn.

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