Class 1 Recall of Infant Apnea Monitor
Respironics, the manufacturer of the SmartMonitor 2 Infant Apnea Monitor, announced that it has voluntarily recalled 4,992 infant apnea monitors. The device continuously monitors infant respiration and heart rate in the hospital or in the infant’s home or in the hospital. The monitor was designed to detect, and sound an alarm for, periods of temporary interruption of breathing (central apnea) or low heart rates. The FDA announced that the Class 1 recall is necessary to protect consumers from serious injury.
Class 1 is the most serious degree of recall, involving a reasonable probability that use of affected products will cause serious injury or death.
This recall applies to SmartMonitor 2 models 4002 and 4003 — caregivers and/or parents using a SmartMonitor 2 Infant Apnea Monitor for their infant should contact their homecare provider immediately to determine if their device is affected. However, they should continue using the apnea monitor until it is replaced, unless directed otherwise by a physician.
Any adverse reactions experienced with the use of this device should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.