Home / Recalls / Medical Devices
PYRAMES INC recalls Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Recalled April 9, 2025 · FDA recall Z-1508-2025 · PYRAMES
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. · FDA Class II
Units
35
Sold at
US distribution to states of: MA and CA
Description
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.
Product
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Manufacturer(s)
PYRAMES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →