BEUDAMED
    FDA Enforcement Class II Terminated

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    Recall: Z-0732-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0732-2017
    Event ID
    75460
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GF Health Products, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    September 30, 2016
    Classification Date
    December 12, 2016
    Termination Date
    April 29, 2019
    Address
    336 Trowbridge Dr, Fond Du Lac, WI, 54937-9103, United States

    Description

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    Reason

    GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.

    Code Info

    BED SERIAL NUMBER RANGE US0458 / US0468 Patriot Full Electric 120V 697142145108 through 697142147927 US0458 / US0468 Patriot Full Electric 220V 697144140132 through 697144140172 US6000 Patriot LX Full Electric 120V 69204141262 through 69204141737 SERVICE MOTOR KITS WITH SHIP DATES OF MAY 4, 2015 THROUGH JUNE 30, 2016 Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    Distribution

    Worldwide Distribution - USA ( nationwide) Distribution including Puerto Rico and to the countries of : Bahamas, Canada, Chile, El Salvador and Santo Domingo.

    Quantity

    3,547 (3063 beds, 484 motors)