BEUDAMED
    FDA Recall Terminated

    Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

    Recall: Z-1474-2012 · Initiated February 22, 2012

    Recall

    Recall Number
    Z-1474-2012
    Event Number
    61328
    Firm
    Visicu, Inc.
    FEI Number
    3003063823
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    February 22, 2012
    Posted
    April 27, 2012
    Terminated
    July 6, 2012
    Address
    217 E Redwood St, Ste 1900, Baltimore, MD, 21202-3315

    Description

    Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

    Reason

    Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.

    Action

    Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.

    Distribution

    Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.

    Quantity

    12