Tag: FDA Warning Letter

WASHINGTON – The U.S. Food and Drug Administration on Nov. 18 sent Invacare a warning letter outlining a number of violations found during an inspection earlier this year.  The violations include, but are not limited to, the following:  Failure to investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation...

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...