Recall Z-2478-2025 ยท REM Spectroscopy Instrument
WASATCH PHOTONICS
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.
| Date | Sep 11, 2025 (initiated Aug 4, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Notifications will be sent out to all purchasers of affected models. Notification will include an offer of free RMA (return to factory for repair, then shipment back to customer). All repairs will be performed at the site of original manufacture in Morrisville, NC. Customer notifications to be delivered by 31-Aug-2025. |
| Quantity | 192 |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.