BEUDAMED
    FDA Recall Completed

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    Recall: Z-2338-2020 · Initiated April 19, 2019

    Recall

    Recall Number
    Z-2338-2020
    Event Number
    85499
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    LLZ
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    April 19, 2019
    Address
    4430 Rosewood Drive, Suite 200, Pleasanton, CA, 94588

    Description

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    Reason

    Images may potentially become corrupt while using the system.

    Action

    The recalling firm issued a customer information letter beginning April 29, 2019, via FedEx (for the U.S. and Canadian customers) informing the consignee of the issue, their site was affected, and a time needed to be scheduled for an onsite visit.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, LA, MA, MI, MO, NC, NH, NY, OR, and TX. There was government distribution but no military distribution. The countries of Canada, Brazil, Ireland, New Zealand, United Arab Emirates, and the United Kingdom.

    Quantity

    26 units