BEUDAMED
    FDA Recall Terminated

    NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)

    Recall: Z-1554-2020 · Initiated February 14, 2020

    Recall

    Recall Number
    Z-1554-2020
    Event Number
    85010
    Firm
    Hill-Rom Inc.
    FEI Number
    2027454
    Product Code
    KMI
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    February 14, 2020
    Terminated
    February 11, 2021
    Address
    1225 Crescent Grn, Ste 300, Cary, NC, 27518-8119

    Description

    NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)

    Reason

    There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.

    Action

    The firm issued a Urgent Medical Device notification on 02/14/2020 by letter. The letter identified the reason and requested the following actions be taken: 1. Hillrom is recommending customers disable the NPS software module, including monitoring for Bed Exit Not Armed, to avoid the potential for staff being unaware of the bed exit state. 2. With the NPS software disabled, caregivers will need to return to manually arming the bed exit to alert for patients exiting the bed. Hillrom is developing a software update for NaviCare Patient Safety and anticipates availability in April 2020. Next Steps: Hillrom will be reaching out to assist you with disabling the software module and plan your upgrade. If you have any questions, or would like to proactively schedule an upgrade, please contact Hillrom Technical Support at 1-800-445-3720, option 3 (Cary), option 1 (NaviCare Nurse Call).

    Distribution

    Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.

    Quantity

    35 Software Systems