Defective Baby Monitor Recalled by FDA

The U.S. Food and Drug Administration recently recalled SmartMonitor 2 Infant Apnea Monitor, classifying the recall as Class I. 

Class I recalls are the most serious recalls a defective product can be labeled with, which means the product has a reasonable probability of causing serious injury or death.

The models that have been recalled are SmartMonitor 2 Infant Apnea Monitor 4002 and 4003.

The device is used by both medical professionals and parents for monitoring infant breathing and heart rate while in the hospital or at home. The recall was issued after reports claimed the device failed to alarm when a baby stopped breathing and when the baby's heart rate slowed down to dangerously low levels.

The FDA has issued a warning to alert all consumers, hospitals, and healthcare providers to stop using the product immediately, return all devices to the company, and report any problems to their doctors and the FDA. Consumers are also urged to contact Respironics, Inc., the company that manufacturers the device, of any problems or complications as well.

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