Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2478-2025

August 04, 2025

Class II

Product summary

Firm
WASATCH PHOTONICS
Event
Event 97520
Status
Ongoing
Classification
Class II
Quantity
192
Official record key
device-enforcement:Z-2478-2025

Official wording

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 information: all codes included in the model numbers.

Distribution pattern: U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.