FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2478-2025
- Recalling firm
- WASATCH PHOTONICS
- 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.
- Status
- Open, Classified
- Initiated
- 2025-08-04
- Posted
- 2025-09-11
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- all codes included in the model numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REM
- Firm FEI
- 3014813917
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28