BEUDAMED
    FDA Enforcement Class II Ongoing

    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

    Recall: Z-1946-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-1946-2024
    Event ID
    94748
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Newport Corp
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    March 27, 2024
    Classification Date
    June 5, 2024
    Address
    Unknown Street, N/A, Ivine, CA, 92606, United States

    Description

    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

    Reason

    According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.

    Code Info

    P/N N-LHP-928 Set S/N (laser head + power supply): 6905AE, 6907AE, 9023AE, 3148AF, 6899AE 6909AE, 9025AE, 5695AF, 5696AF, 5691AF, 5692AF, 5693AF, 5694AF (9 of them in Irvine warehouse) P/N: N6-LPL-944-080 Power supply S/N: 23060081, 23060079

    Distribution

    US Nationwide

    Quantity

    19