BEUDAMED
    FDA Recall Terminated

    Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.

    Recall: Z-2337-2020 · Initiated May 19, 2020

    Recall

    Recall Number
    Z-2337-2020
    Event Number
    85729
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 19, 2020
    Terminated
    August 25, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.

    Reason

    Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.

    Action

    On May 19, 2020, the firm sent the affected customer an URGENT Medical Device Removal letter, informing them of the issue. The firm is unaware of any other pre-production VM1 devices in distribution. The customer was asked to immediately locate the affected unit, remove it from clinical use, and quarantine the device in a secure location. A Philips representative will contact the customer to arrange for the removal of the affected unit. Customers with questions may contact their local Philips representative or call 1-800-722-9377.

    Distribution

    US Nationwide distribution including in the state of NJ.

    Quantity

    1