BEUDAMED
    FDA Recall Terminated

    Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107

    Recall: Z-1776-2008 · Initiated April 11, 2008

    Recall

    Recall Number
    Z-1776-2008
    Event Number
    47807
    Firm
    Pride Mobility Products Corp
    FEI Number
    3005068474
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 11, 2008
    Posted
    August 27, 2008
    Terminated
    November 13, 2009
    Address
    182 Susquehanna Ave, Exeter, PA, 18643-2653

    Description

    Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107

    Reason

    Software - Watch dog timer feature was disabled.

    Action

    The recalling firm issued an Urgent Device Correction letter on 4/11/08. This letter instructs the dealers to contact the end users so that the units can be upgraded to enable the watch dog feature.

    Distribution

    Class II Recall - Worldwide Distribution --- including USA and Canada.

    Quantity

    4129