BEUDAMED
    FDA Enforcement Class II Ongoing

    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,

    Recall: Z-1472-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1472-2023
    Event ID
    91938
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    April 5, 2023
    Classification Date
    April 27, 2023
    Address
    6 Tech Dr, N/A, Andover, MA, 01810-2434, United States

    Description

    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,

    Reason

    The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

    Code Info

    UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    19,429 systems