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Class I Recall for Infant Apnea Monitors Made by Respironics, Inc.

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Just over 4,900 defective SmartMonitor 2 infant apnea monitors are being recalled by Respironics, Inc. of Murrysville, PA.  According to the recall notice, the infant apnea monitors may not issue an alarm when needed.

The Food & Drug Administration (FDA) has classified the Respironics SmartMonitor 2 infant apnea monitor recall a Class I recall, the agency’s most serious type.  Class I recalls are issued when there is a  reasonable probability that use of a device will cause serious injury or death. 

The recall includes models 4002 and 4003 with serial numbers 3000033364 through 3000038740.  The SmartMonitor 2 infant apnea monitors subject to this recall were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.

The SmartMonitor 2 infant apnea monitors are intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of interrupted breathing and high or low heart rates.

According to the FDA, Respironics sent a letter dated April 23, 2009 to  medical supply companies informing them of the potentially defective SmartMonitor 2 infant apnea monitors. The firm requested the companies return all units in their inventory.  The supply firms were also asked to  retrieve and return all units already shipped to patients.

Customers with questions regarding the SmartMonitor 2 infant apnea monitor recall may  contact  Respironics at 1-888-345-4630.

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