BEUDAMED
    FDA Recall 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 · Initiated May 1, 2017

    Recall

    Recall Number
    Z-2250-2017
    Event Number
    77176
    Firm
    Circadiance LLC
    FEI Number
    3006182632
    Product Code
    NPE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 1, 2017
    Terminated
    February 5, 2018
    Address
    1060 Corporate Ln, Export, PA, 15632-8905

    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.

    Action

    Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to [email protected]. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free of charge, or for questions or support.

    Distribution

    Nationwide Distribution.

    Quantity

    1,242 units