BEUDAMED
    FDA Recall Terminated

    CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    Recall: Z-1436-2009 · Initiated May 5, 2009

    Recall

    Recall Number
    Z-1436-2009
    Event Number
    51982
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 5, 2009
    Posted
    May 27, 2009
    Terminated
    March 6, 2012
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    Reason

    Software: A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period

    Action

    Philips Medical notified accounts by letter on 5/6/09 the 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 CareVue Chart 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. Philips is currently developing a correction that will be available at no additional charge. A Philips representative will notify customers when the software correction becomes available. If further assistance is needed, customers are to contact the Philips Customer Care Center at 1-800-722-9377.

    Distribution

    Worldwide Distribution -- USA including states of CA, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom.

    Quantity

    103 units