BEUDAMED
    FDA Enforcement Class II 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 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2376-2016
    Event ID
    74615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    June 14, 2016
    Classification Date
    August 9, 2016
    Termination Date
    May 15, 2017
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520, United States

    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.

    Code Info

    All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.

    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