BEUDAMED
    FDA Recall Terminated

    Progressa Bed - AC-powered adjustable hospital bed

    Recall: Z-1319-2018 · Initiated January 12, 2018

    Recall

    Recall Number
    Z-1319-2018
    Event Number
    79516
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    January 12, 2018
    Terminated
    June 26, 2020
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    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.

    Action

    Firm has developed a correction for the braking system and plan to have a Hill-Rom technician to update affected Progressa Beds. Hill-Rom sent a letter, dated January 12, 2018. Until beds are updated, follow the safety information as outlined in the Progressa User manual each time when setting the brakes. Warning: Always set the brakes when the bed is occupied, except during patient transport. To help make sure the bed will not move, push and pull on the bed to check it after the brakes are engaged. Brakes should always be set when the bed is occupied and especially when moving a patient from one surface to another. Patients often use the bed for support when getting out of bed and could be injured if the bed unexpectedly moves. After setting the brakes, push and pull the bed to make sure of stability. If the brakes do not hold after following the instructions above, take the bed out of service until the bed is updated.

    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