BEUDAMED
    FDA Recall Terminated

    Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management.

    Recall: Z-1654-2009 · Initiated May 5, 2009

    Recall

    Recall Number
    Z-1654-2009
    Event Number
    51979
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 5, 2009
    Posted
    July 7, 2009
    Terminated
    February 6, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management.

    Reason

    Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.

    Action

    Philips notified customers by Urgent Medical Device Correction Notification letter on May 6, 2009. The Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software corrections. The corrections will be in the form of software upgrades and will be performed by Philips service personnel. On May 27, 2009, Philips issued the second Urgent Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within lCIP to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist.

    Distribution

    Worldwide distribution, including USA, Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UAE, and UK.

    Quantity

    105 units