BEUDAMED
    FDA Recall Terminated

    Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S.

    Recall: Z-0584-2008 · Initiated November 21, 2007

    Recall

    Recall Number
    Z-0584-2008
    Event Number
    45807
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    KNC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 21, 2007
    Posted
    February 22, 2008
    Terminated
    September 22, 2009
    Address
    125 E Pearl St, Batesville, IN, 47006

    Description

    Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S.

    Reason

    Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.

    Action

    Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.

    Distribution

    Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, The Netherlands, New Calidonia, New Zealand, Nigeria, Northern Mariana Islands, Norway, Oman, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Singapore, South Korea, Romania, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguey, Venezuela, and Virgin Islands .

    Quantity

    32,379 for all model numbers