Class II
Medical Device Recall: 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.
WASATCH PHOTONICS · August 4, 2025
Reason for Recall
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.
Distribution
U.S.
Quantity Affected
192
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2478-2025
Status: ongoing
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