FDA-Device2025-09-17Class II

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
Hazard

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.

Sold states
U.S.
Affected count
192
Manufactured in
808 Aviation Pkwy Ste 1400, N/A, Morrisville, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2478-2025

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