BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated August 4, 2025

    Recall

    Recall Number
    Z-2478-2025
    Event Number
    97520
    Firm
    WASATCH PHOTONICS
    FEI Number
    3014813917
    Product Code
    REM
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 4, 2025
    Posted
    September 11, 2025
    Address
    808 Aviation Pkwy, Ste 1400, Morrisville, NC, 27560-6600

    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.

    Action

    Notifications will be sent out to all purchasers of affected models. Notification will include an offer of free RMA (return to factory for repair, then shipment back to customer). All repairs will be performed at the site of original manufacture in Morrisville, NC. Customer notifications to be delivered by 31-Aug-2025.

    Distribution

    U.S.

    Quantity

    192