Skip to Content

Tag: FDA warning letter


Also Noted

FDA warns Philips Respironics over Smart Monitor 2

July 10, 2014HME News Staff

MURRYSVILLE, Pa. - The U.S. Food and Drug Administration (FDA) has sent a warning letter to Philips Respironics about the batteries used in its Smart Monitor 2. The June 30 letter said batteries in the apnea monitor were not properly examined or tested “causing the units to constantly alarm, not allowing continuous monitoring of respiration, heart rate and oxygen saturation of infant and pediatric patients.” Philips says inspectors found “a limited number” of incorrectly wired...

FDA warning letter, philips respironics


Read Full Articlered right arrow icon