Infant Apnea Monitor Recall

A medical device designed to monitor the breathing and heart rate of infants in hospitals and homes is being recalled for an alarm system failure. According to the FDA recall notice, the Smart Monitor 2 manufactured by Respironics, Inc. has failed to warn doctors, caregivers, and parents of a suddent change in an infant’s heart rate or breathing pattern. The model numbers involved in the recall are Models 4002 and 4003 with serial numbers 3000033364 through 3000038740. The product was made January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
The FDA has classified this as a Class I recall meaning use of these medical devices have a reasonable probability of serious injury or death if used.