FDA-Device2025-04-09Class II
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
PYRAMES INC
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.
Sold states
US distribution to states of: MA and CA
Affected count
35
Manufactured in
21730 Stevns Crk Blvd Ste 201a, Cupertino, CA, United States
Products
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1508-2025Don't want to check this manually?
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