BEUDAMED
    FDA Enforcement Class II Terminated

    Progressa Bed - AC-powered adjustable hospital bed

    Recall: Z-1319-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1319-2018
    Event ID
    79516
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    January 12, 2018
    Classification Date
    April 9, 2018
    Termination Date
    June 26, 2020
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520, United States

    Description

    Progressa Bed - AC-powered adjustable hospital bed

    Reason

    A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.

    Code Info

    S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017

    Distribution

    Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.

    Quantity

    2117