Apnea monitor recall
This article was originally published in The Gray Sheet
Executive Summary
FDA labels Philips/Respironics' April recall of its SmartMonitor 2 infant apnea monitor a Class I action May 18, signifying the highest level of risk. The firm instructed medical supply companies on April 23 to return all units of the product, including those already shipped to patients, in response to a finding that the device may fail to sound an alarm if there is a temporary interruption of breathing or low heart rates. SmartMonitor 2 is used for continuous monitoring of respiration and heart rate in infants at home or in the hospital