BEUDAMED
    FDA Enforcement Class II Ongoing

    Sit to Stand STS500 Patient Lift

    Recall: Z-1205-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1205-2023
    Event ID
    91695
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Med-Mizer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 8, 2023
    Initiation Date
    February 3, 2023
    Classification Date
    March 2, 2023
    Address
    80 Commerce Dr, N/A, Batesville, IN, 47006-6700, United States

    Description

    Sit to Stand STS500 Patient Lift

    Reason

    Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.

    Code Info

    UDI-DI: 00852195007353; Serial No.: STS500000, STS500001, STS500002, STS500003, STS500004, STS500005, STS500006, STS500007, STS500008, STS500009, STS500010, STS500011, STS500012, STS500013, STS500014, STS500015, STS500016, STS500017, STS500018, STS500019, STS500020, STS500021, STS500022, STS500023, STS500024, STS500025, STS500026, STS500027, STS500028, STS500029, STS500030, STS500031, STS500032, STS500033, STS500034, STS500035, and STS500036.

    Distribution

    Awaiting consignee list from the recalling firm.

    Quantity

    37 units