BEUDAMED
    FDA Enforcement Class II Terminated

    Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.

    Recall: Z-1466-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1466-2013
    Event ID
    65257
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 15, 2013
    Classification Date
    June 5, 2013
    Termination Date
    February 7, 2017
    Address
    1069 State Road 46 E, N/A, Batesville, IN, 47006-7520, United States

    Description

    Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.

    Reason

    Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.

    Code Info

    Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.

    Distribution

    Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.

    Quantity

    8,737 devices