BEUDAMED
    FDA Recall Terminated

    ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

    Recall: Z-0026-2007 · Initiated April 5, 2006

    Recall

    Recall Number
    Z-0026-2007
    Event Number
    36125
    Firm
    Extended Care Air Therapy Systems Inc
    FEI Number
    3002498894
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2006
    Posted
    October 14, 2006
    Terminated
    September 21, 2012
    Address
    7165 Payne Rd, Roseville, OH, 43777-9711

    Description

    ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

    Reason

    Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall

    Action

    The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.

    Distribution

    The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.

    Quantity

    102 beds