BEUDAMED
    FDA Recall Terminated

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.

    Recall: Z-1541-2014 · Initiated April 18, 2014

    Recall

    Recall Number
    Z-1541-2014
    Event Number
    67871
    Firm
    Med-Mizer, Inc.
    FEI Number
    3004976058
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    April 18, 2014
    Posted
    May 2, 2014
    Terminated
    May 23, 2016
    Address
    80 Commerce Dr, Batesville, IN, 47006-6700

    Description

    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 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

    Action

    On 5/1/14, Med-Mizer sent URGENT: MEDICAL DEVICE RECALL notification to their consignees. Notification included description of the affected product, reason for recall, risk to health, instructions on how to recognize how the device may fail, and instructions for actions to be completed by their consignees. Contact Information: 1-877-867-7365, [email protected], 8am-5pm EST.

    Distribution

    USA (nationwide)

    Quantity

    191