BEUDAMED
    FDA Enforcement Class II Terminated

    GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001

    Recall: Z-0241-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0241-2023
    Event ID
    91020
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    October 17, 2022
    Classification Date
    November 16, 2022
    Termination Date
    May 28, 2024
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001

    Reason

    Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

    Code Info

    UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002

    Distribution

    US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.

    Quantity

    5 units