BEUDAMED
    FDA Recall Terminated

    Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.

    Recall: Z-0548-2010 · Initiated November 16, 2009

    Recall

    Recall Number
    Z-0548-2010
    Event Number
    53987
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    HDD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2009
    Posted
    December 17, 2009
    Terminated
    July 2, 2012
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520

    Description

    Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.

    Reason

    The brakes may not hold or lock.

    Action

    Hill-Rom issued an "Urgent Safety Notice" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections. For further information, contact Hill-Rom Technical Support at 1-800-445-3720.

    Distribution

    Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libiya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Syria, Thailand, Turkey and United Arab Emirates.

    Quantity

    2551 (US), 4171 (OUS)