BEUDAMED
    FDA Recall Terminated

    Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006

    Recall: Z-0617-2008 · Initiated September 6, 2007

    Recall

    Recall Number
    Z-0617-2008
    Event Number
    45444
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    HDD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 6, 2007
    Posted
    April 2, 2008
    Terminated
    October 15, 2010
    Address
    125 E Pearl St, Batesville, IN, 47006

    Description

    Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006

    Reason

    Brake failure: The brakes may not hold or lock properly.

    Action

    Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.

    Distribution

    Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Norway, Philippines, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syria, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    1,796