Respironics Inc has initiated a recall of its SmartMonitor 2 infant apnea monitor (models 4002 and 4003) via a letter send to its medical supply companies, because the device may fail to sound an alarm. The FDA issued a notice on May 18, 2009.
The original recall notice from the company on April 23, 2009, requests that customers return all units in their inventory and retrieve and return all units already shipped to patients.
The device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital, and was manufactured from January 16, 2008 through November 13, 2008, and distributed from January 17, 2008 through December 31, 2008.
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.
Contact the company at (888) 345-4630 for more information. The complete recall notice is available on the FDA Web site.
