Z-2478-2025 Class II Ongoing
FDA device recall Z-2478-2025 was initiated by WASATCH PHOTONICS on August 4, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 192.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- August 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 192
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.
Distribution Pattern
U.S.
Code Information
all codes included in the model numbers.