BEUDAMED
    FDA Recall Open, Classified

    B125M Patient Monitor, REF 6160000-005-XXXXXXX

    Recall: Z-0733-2023 · Initiated November 16, 2022

    Recall

    Recall Number
    Z-0733-2023
    Event Number
    91176
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 16, 2022
    Posted
    December 19, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    B125M Patient Monitor, REF 6160000-005-XXXXXXX

    Reason

    GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

    Action

    GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/16/2022. The notice explained the problem and safety issue and requested the following: "You can determine whether your monitor is impacted by looking at the side of your monitor where the parameter acquisition connectors are located. B1x5P with E-module slot option and all B1x5M patient monitors are impacted (See Figure 1). B1x5P patient monitors without E-module slot option are not impacted (See Figure 2). You can also determine whether your monitor is impacted following the affected product directions below. You can continue to use the affected monitors by following the safety instructions below. 1. Use CO2 measurement in % unit by following the below steps on the B1x5P / B1x5M monitor. a. From the Main Screen, click the CO2 digit field; b. Select Setup > Unit; c. Select % from the dropdown list. OR If available, you can also insert the GE Healthcare gas E-module for CO2 measurement directly into the E-module slot of the GE Healthcare anesthesia delivery systems (Carestation 600 Series, Carestation 750, Avance CS2, and Aisys CS2) or CARESCAPE R860 ventilator, as the CO2 measurement values displayed on these machines are correct in all "%", mmHg , and kPa units." "If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative." The affected products will be updated.

    Distribution

    Worldwide distribution.

    Quantity

    3348 units