BEUDAMED
    FDA Enforcement Class II Terminated

    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.

    Recall: Z-2250-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2250-2017
    Event ID
    77176
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Circadiance LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    May 1, 2017
    Classification Date
    June 6, 2017
    Termination Date
    February 5, 2018
    Address
    1060 Corporate Ln, N/A, Export, PA, 15632-8905, United States

    Description

    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.

    Reason

    Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.

    Code Info

    Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140. All serial numbers of units with "REF", "MODEL" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice. Monitors with the above part numbers that have a serial number starting with "CP" are NOT affected by this issue.

    Distribution

    Nationwide Distribution.

    Quantity

    1,242 units