MedWatch – The FDA Safety Information and Adverse Event Reporting Program
Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003
Audience: Consumers, Pediatricians
Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice, at: