BEUDAMED
    FDA Enforcement Class II Terminated

    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.

    Recall: Z-1646-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1646-2014
    Event ID
    68262
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Informatics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    May 5, 2014
    Classification Date
    May 21, 2014
    Termination Date
    April 28, 2015
    Address
    4100 E 3rd Ave Ste 101, N/A, Foster City, CA, 94404-4819, United States

    Description

    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.

    Reason

    When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed

    Code Info

    Model XIRIS 8.1 version XIRIS 8.1.50.0

    Distribution

    Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.

    Quantity

    5 units