BEUDAMED
    FDA Recall Terminated

    Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.

    Recall: Z-1942-2012 · Initiated June 14, 2012

    Recall

    Recall Number
    Z-1942-2012
    Event Number
    62270
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    OUG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 14, 2012
    Posted
    July 5, 2012
    Terminated
    March 14, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.

    Reason

    Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface

    Action

    Philips Healthcare sent an "URGENT-FIELD SAFETY NOTICE" letter dated June 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Philips representative will contact customers when the upgrade becomes available. Contact your local Philips Representative for questions concerning this issue.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.

    Quantity

    226 units