BEUDAMED
    FDA Enforcement Class II Ongoing

    Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

    Recall: Z-1508-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1508-2025
    Event ID
    96414
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PYRAMES INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 9, 2025
    Initiation Date
    February 24, 2025
    Classification Date
    April 2, 2025
    Address
    21730 Stevns Crk Blvd Ste 201a, Cupertino, CA, 95014-1171, United States

    Description

    Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

    Reason

    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.

    Code Info

    Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301

    Distribution

    US distribution to states of: MA and CA

    Quantity

    35