BEUDAMED
    FDA Recall Terminated

    Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006

    Recall: Z-0240-2008 · Initiated November 12, 2006

    Recall

    Recall Number
    Z-0240-2008
    Event Number
    38256
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FIN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 12, 2006
    Posted
    July 24, 2007
    Terminated
    October 22, 2010
    Address
    125 E Pearl St, Batesville, IN, 47006

    Description

    Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006

    Reason

    False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle.

    Action

    The firm notified consignees via an Urgent Device Correction letter dated 11/12/07 informing them of the problem and informed them they would be receiving upgrade kits which they could have their qualified personnel install themselves following video instructions also provided, or they could contact Hill-Rom for assistance.

    Distribution

    Worldwide, including USA, Argentina, Australia, Brazil, Canada, Dominican Republic, Emirate of Sharjah, England, Greece, Indonesia, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Selangor, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates and Venezuela.

    Quantity

    43,731 beds total for both models were distributed; 3,282 have been corrected to date.