July 2009 (09NB-198)

In cooperation with a Pennsylvania manufacturer, the U.S. Food and Drug Administration (FDA) has announced a Class 1 recall of certain models of infant apnea monitors.

These medical devices are used for the continuous monitoring of the respiration and heart rate of infant patients in the home or in the hospital. The devices detect periods of temporary interruption of breathing or low hearts, and sound an alarm in such circumstances.

According to a notice issued by the FDA, the recalled devices may fail to sound an alarm under certain circumstances. A Class 1 recall is the most serious type of recall and involves situations in which the use of the device will cause serious injury or death.

To view the FDA notice of this recall, view:

http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm152725.htm

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