The US Food and Drug Administration (FDA) issued a [removed]Class 1 recall[/removed] on the Philips Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003). The recall issued in late April affects those models with serial numbers 3000033364 through 3000038740.
The SmartMonitor 2 Infant Apnea Monitor is used for the continuous monitoring of respiration and heart rate of infant patients in homes or in hospitals. The recall was issued because of indications that the device may not sound the alarm that indicates apneas or low heart rates have been detected.
Philips Respironics has requested that companies with the monitors in this recall take the following actions:
• return all units in their inventory
• retrieve and return all units already shipped to patients
“Class 1 recalls are the most serious type of recall issued by the FDA and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death,” states the FDA Web site.