BEUDAMED
    FDA Recall Terminated

    Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.

    Recall: Z-2562-2014 · Initiated June 26, 2014

    Recall

    Recall Number
    Z-2562-2014
    Event Number
    68650
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    KNC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 26, 2014
    Posted
    September 1, 2014
    Terminated
    July 14, 2017
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    Description

    Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.

    Reason

    The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall.

    Action

    Hill-rom issued an Urgent Field Safety Notice letter dated June 26, 2014 to affected customers. The Notification identified the affected product issue and instructions for product inspection. The letter states that the firm is working on making changes to the Lift-Off foot section that will mitigate risk even if damage was to occur. If you have any questions concerning the notice or requested procedure, please contact Hill-Rom Technical Support at 800-445-3720.

    Distribution

    Worldwide Distribution - US Nationwide and the following countries: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Belize, Bermuda, Brazil, Brunei, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, US Virgin Islands, Venezuela and Vietnam.

    Quantity

    13,000 units