BEUDAMED
    FDA Enforcement Class II Terminated

    Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).

    Recall: Z-1947-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1947-2020
    Event ID
    85431
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunrise Medical (US) LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    February 13, 2020
    Classification Date
    May 11, 2020
    Termination Date
    April 28, 2021
    Address
    2842 N Business Park Ave, N/A, Fresno, CA, 93727-1328, United States

    Description

    Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).

    Reason

    Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.

    Code Info

    Q700M wheelchair S/N Q7MP-083941. UDI:(01)05022408059799. Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). Controller label: D50903.15 CR19100531.

    Distribution

    Distributed to US Consignee in MT.

    Quantity

    1