BEUDAMED
    FDA Recall Terminated

    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325

    Recall: Z-0549-2022 · Initiated January 3, 2022

    Recall

    Recall Number
    Z-0549-2022
    Event Number
    89489
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 3, 2022
    Terminated
    April 11, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325

    Reason

    eCareManager (eCM) Sentry Score software not approved for use

    Action

    Philips issued Urgent Medical Device Correction letter eCareManager (eCM) Sentry Score to customers via email on 03-Jan-2022. FedEx letters delivered 05-Jan-2022 or 06-Jan-2022. Letter states reason for recall, health risk and action to take: 1 Stop using Sentry Score immediately 2 Share this communication with eCareManager users/Clinicians/ Health Care providers within your organization as soon as possible. 3 Complete the Urgent Medical Device Correction Response form and return to Philips via any one of the below methods: - Email - [email protected] - FedEx Please use the return envelope. The correction will be accomplished in 2 steps Step 1: Philips will contact you to schedule approximately 10 minutes of down time for eCareManager as soon as possible, at your convenience. During this downtime the configuration will be updated, so that Sentry Score will not be accessible. This means you will no longer be able to use Sentry Score. All other functions of eCareManager will continue to work as intended. Step 2: Philips will be creating a software update package, which will be installed at your site for the version of eCareManager software that is running on your system. Sentry Score will be removed from the software as well as any reference to Sentry Score on any of the screens via the software update package. All appropriate documents (clinical user guide etc.) will be provided to you as part of this update. As soon as the software update packages are available, you will be contacted by Philips to update the system with the software update package to remove Sentry Score. If you need any further information or support concerning this issue, please contact your local Philips representative: Email: [email protected]

    Distribution

    Worldwide distribution - US Nationwide and the country of Australia.

    Quantity

    36 units