BEUDAMED
    FDA Recall Terminated

    Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed 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. They are not intended for use as general hospital beds.

    Recall: Z-2082-2012 · Initiated April 2, 2012

    Recall

    Recall Number
    Z-2082-2012
    Event Number
    62453
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    KNC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 2, 2012
    Posted
    July 26, 2012
    Terminated
    July 21, 2015
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520

    Description

    Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed 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. They are not intended for use as general hospital beds.

    Reason

    During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural

    Action

    Hill-Rom sent an URGENT FIELD SAFETY NOTICE letter dated April 2, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were informed that Hill-Rom will visit their facility to modify the affected products, however, until then follow the actions to be taken outlined. For questions concerning this request or the procedure as outlined contact Hill-Rom Technical Support at 800-445-3720 (U.S.).

    Distribution

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

    Quantity

    12,726 devices