BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0596-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0596-2016
    Event ID
    72879
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    December 9, 2015
    Classification Date
    January 6, 2016
    Termination Date
    August 8, 2016
    Address
    22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States

    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.

    Code Info

    System Serial numbers: USD15L0177; USD15L0178; USD15L0179; USD15L0297; USD15L0298; USN15L0789; USN15L0862; USN15L0863; USN15L0864; USN15L0865; USN15L0866; USN15L0867; USN15L0917; USN15L0918; USN15L0988; USO15L0563; USO15L0564; USO15L0565; USO15L0566; USO15L1087; and USO15L1088.

    Distribution

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

    Quantity

    21 units in the US only