Recall Z-2478-2025— WASATCH PHOTONICS
Class II · Ongoing
Class II FDA medical device recall by WASATCH PHOTONICS, initiated 2025-08-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- WASATCH PHOTONICS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-04
- Firm location
- Morrisville, NC, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.