May 19, 2009 
Respironics Inc. is recalling the SmartMonitor 2 infant panea monitor, models 4002 and 4003 with serial numbers 3000033364 through 3000038740, because it may fail to sound an alarm.
This product was manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
The device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.
On April 23, 2009, the firm sent a letter to their medical supply companies informing them of the potential problem. The firm requested the companies 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 and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
