BEUDAMED
    FDA Recall 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 · Initiated May 5, 2014

    Recall

    Recall Number
    Z-1646-2014
    Event Number
    68262
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    OUG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 5, 2014
    Posted
    May 21, 2014
    Terminated
    April 28, 2015
    Address
    4100 E 3rd Ave, Ste 101, Foster City, CA, 94404-4819

    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

    Action

    Philips Healthcare sent an Urgent Field Safety Notice dated May 5, 2014. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the synchronization problem and request that a copy of this notification be kept with the equipment instructions for use. The document goes on to outline the affected product, the problems and conditions when it can occur. A photo of the label for easy identity the actions to be taken are provided. Philips is informing users of the issue via the notification and will deploy a software correction to all customers when available. Questions may be directed to Philips reps or Care at 1-866-946-4701 or [email protected]

    Distribution

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

    Quantity

    5 units