BEUDAMED
    FDA Recall Terminated

    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.

    Recall: Z-2376-2016 · Initiated June 14, 2016

    Recall

    Recall Number
    Z-2376-2016
    Event Number
    74615
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 14, 2016
    Posted
    August 9, 2016
    Terminated
    May 15, 2017
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    Description

    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.

    Reason

    The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.

    Action

    Hill-Rom sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June 14, 2016 to the affected US and Canadian customers via email and courier, international customers. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The letter requests the number of beds in the consignees possession so that repair kits can be provided. If you have any questions regarding this safety notice, contact Hill-Rom Technical Support at 1-800-445-3720, your distributor, your Hill-Rom representative or contact us on www.hill-rom.com.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    24262