BEUDAMED
    FDA Enforcement Class II Terminated

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

    Recall: Z-1542-2014 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1542-2014
    Event ID
    67871
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med-Mizer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 14, 2014
    Initiation Date
    April 18, 2014
    Classification Date
    May 2, 2014
    Termination Date
    May 23, 2016
    Address
    80 Commerce Dr, N/A, Batesville, IN, 47006-6700, United States

    Description

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

    Reason

    All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th

    Code Info

    Serial Number 2000

    Distribution

    USA (nationwide)

    Quantity

    1