BEUDAMED
    FDA Recall Terminated

    Hill-Rom 1000 bed model P1160.

    Recall: Z-2268-2010 · Initiated April 13, 2009

    Recall

    Recall Number
    Z-2268-2010
    Event Number
    55156
    Firm
    Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006
    FEI Number
    1824206
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 13, 2009
    Posted
    August 24, 2010
    Terminated
    June 6, 2011

    Description

    Hill-Rom 1000 bed model P1160.

    Reason

    Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.

    Action

    Hill-Rom sent a customer notification letter dated 4/9/2009. A second notice was sent to all customers on 7/9/2009. The letter included instructions and a Customer Response Form, along with the required parts. Customers were instructed to do the correction on their affected beds and return the completed customer response form within 45 days.

    Distribution

    Worldwide distribution: USA, Afghanistan, Algeria, American Samoa, Argentina, Australia, Bermuda, Brazil, Canada, Chili, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Kyrgyzstan, Lebanon, Libya, Malaysia, Mexico, Oman, Panama, Paraguay, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Syria, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.

    Quantity

    39,971 both products