BEUDAMED
    FDA Enforcement Class II Terminated

    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.

    Recall: Z-1632-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1632-2020
    Event ID
    85154
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merits Holdings Co. dba Merits Health Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2020
    Initiation Date
    March 2, 2020
    Classification Date
    April 1, 2020
    Termination Date
    September 18, 2023
    Address
    4245 Evans Ave, N/A, Fort Myers, FL, 33901-9311, United States

    Description

    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.

    Reason

    Pinion gear may disengage from track allowing lift to slip or jolt.

    Code Info

    Model: E60424YLMUB; SN: MU180600588; (01) 04714379292589 (11)190604 (21) MU190600025.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.

    Quantity

    82 units.