Respironics SmartMonitor 2 Infant Apnea Monitor Recall

About 5,000 baby sleep apnea monitors have been recalled by Respironics, Inc., as the medical devices may fail to sound an audible alarm to alert an adult that the child has stopped breathing, or that their heart rate has dropped.

The infant apnea monitor recall notice was posted by the FDA on May 18, notifying consumers and medical professions of the potential problems that may occur with the Respironics SmartMonitor 2 Infant Apnea Monitor, affecting models 4002 and 4003, with serial numbers 3000033364 through 30000038740.

According to the FDA, the voluntary action has been classified as a Class 1 recall, which is “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.”

A press release from Respironics indicates that they are aware of at least one incident where the audible alarm failed, but no known injuries have resulted from the defect. A warning light that corresponds with the alarm still works as it should, according to the company.

Respironics contacted health care providers and the FDA at the end of April, voluntarily recalling 4,992 units.

Infant apnea monitors are used to continuously track the breathing and heart rate of infant patients at home or in hospitals. The monitor is designed to warn others when the baby suffers periods of interrupted breathing or lowered heart rates.

Apnea is a condition that causes lapses in breathing, which can be particularly dangerous for infants because the resulting lack of oxygen to the brain has been identified as a cause for Sudden Infant Death Syndrome (SIDS).

Parents and caregivers have been urged to contact their home care provider immediately if they suspect they have one of the recalled Respironics SmartMonitor 2 Infant Apnea Monitors, but should continue to use the device until it can be replaced.