BEUDAMED
    FDA Enforcement Class III Terminated

    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.

    Recall: Z-1242-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1242-2018
    Event ID
    79423
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 4, 2018
    Initiation Date
    December 1, 2017
    Classification Date
    March 28, 2018
    Termination Date
    August 29, 2018
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.

    Reason

    The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

    Code Info

    All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.

    Distribution

    Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.

    Quantity

    1719