April 9, 2025Medical DevicesFDA
PYRAMES INC recalls Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Hazard: Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.