BEUDAMED
    FDA Recall 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 · Initiated February 13, 2020

    Recall

    Recall Number
    Z-1947-2020
    Event Number
    85431
    Firm
    Sunrise Medical (US) LLC
    FEI Number
    2937137
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    February 13, 2020
    Posted
    May 11, 2020
    Terminated
    April 28, 2021
    Address
    2842 N Business Park Ave, Fresno, CA, 93727-1328

    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.

    Action

    An URGENT: MEDICAL DEVICE RECALL letter was sent the firm's dealer. The dealer was instructed on February 4, 2020, to replace the controller unit for the device.

    Distribution

    Distributed to US Consignee in MT.

    Quantity

    1