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LAWSUITS NEWS & LEGAL INFORMATION

SmartMonitor 2 Infant Apnea Monitor Recalled by Respironics, FDA


Respironics and FDA have notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor 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 are Models 4002 and 4003 with serial numbers 3000033364 through 3000038740. They were 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.

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Published on May-18-09


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