BEUDAMED
    FDA Enforcement Class II Ongoing

    OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000

    Recall: Z-2068-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2068-2023
    Event ID
    92506
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NeuroLogica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2023
    Initiation Date
    June 6, 2023
    Classification Date
    July 3, 2023
    Address
    14 Electronics Ave, N/A, Danvers, MA, 01923-1011, United States

    Description

    OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000

    Reason

    1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

    Code Info

    GTIN: 10815411020335 10815411020663 Serial Numbers: 10 14 23 25 26 36 38 40 41 42 44 46 48 49 50 51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 15R

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.

    Quantity

    48 units