BEUDAMED
    FDA Recall Terminated

    AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS

    Recall: Z-0063-2007 · Initiated September 27, 2006

    Recall

    Recall Number
    Z-0063-2007
    Event Number
    36410
    Firm
    Invacare Corporation
    FEI Number
    1031452
    Product Code
    LLI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2006
    Posted
    October 24, 2006
    Terminated
    October 5, 2009
    Address
    2101 E. Lake Mary Blvd., Sanford, FL, 32773-7141

    Description

    AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS

    Reason

    The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).

    Action

    E-mails and letters regarding this correction provided to the consignees on September 27, 2006, and to appropriate Invacare personnel for information purposes. Consignees are being notified via delivery of a field correction package. Once the packages have been sent, a notice will be posted on the Invacare website. A follow-up contact will be scheduled in 2 to 3 months to try to reach those who have not returned their tracking sheet indicating completion of their corrective action.

    Distribution

    United States and Canada.

    Quantity

    2065