BEUDAMED
    FDA Recall Terminated

    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)

    Recall: Z-0596-2016 · Initiated December 9, 2015

    Recall

    Recall Number
    Z-0596-2016
    Event Number
    72879
    Firm
    Philips Ultrasound, Inc.
    FEI Number
    3019216
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 9, 2015
    Posted
    January 6, 2016
    Terminated
    August 8, 2016
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)

    Reason

    Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies.

    Action

    Philips began mailing the URGENT - Medical Device Correction Philips Model Lumify Ultrasound System, FSN 79500372, dated 2015 DEC 11, to consignees. Consignees are instructed to do the following: 1. Check the version of software on your system using the instructions provided above on How to Identify Affected Products. Philips has corrected this issue in version 1.0.1 and higher. 2. Connect the tablet to the internet. 3. The system will alert you to download the upgrade from Google Play. 4. Follow all on screen to upgrade the software version. If consignees cannot promptly connect to the internet to download the upgraded software, Philips recommends that you do not use Color Flow. In accordance with the subscription terms and conditions, you will be required to reconnect the system to the internet within no more than 30 days. If consignees do not connect their device to the internet after 30 days, they will be unable to use the system. Consignees with questions should contact your local Philips representative or Philips Customer Service at 1-800-722-9377.

    Distribution

    distributed in CA, CT, ND, NV, OR, RI, TN, and WA.

    Quantity

    21 units in the US only