BEUDAMED
    FDA Enforcement Class II Ongoing

    Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.

    Recall: Z-2478-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2478-2025
    Event ID
    97520
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    WASATCH PHOTONICS
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    September 17, 2025
    Initiation Date
    August 4, 2025
    Classification Date
    September 11, 2025
    Address
    808 Aviation Pkwy Ste 1400, N/A, Morrisville, NC, 27560-6600, United States

    Description

    Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.

    Reason

    Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.

    Code Info

    all codes included in the model numbers.

    Distribution

    U.S.

    Quantity

    192