Raman spectrometers recalled over two newly identified laser safety failure modes
Wasatch Photonics Raman spectrometers are recalled after two potential laser safety failure modes were identified in the product design. The firm states the modes have never been found to occur. 192 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential laser safety failure modes and states they have never been found to occur.
Plain-English summary
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers are being recalled across product models 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC and 785-ER-ILC, covering all codes included in the model numbers. The recall covers 192 units distributed in the United States.
Two new potential laser safety failure modes have been identified in the product design: overcurrent of the laser diode, and a fail-unsafe mode. The manufacturer states the failure modes have never been found to occur in these models, whether in the field or in the factory, but could potentially occur under excessive force or extreme, continuous vibration. The FDA classified the action as Class II.
Users should follow the manufacturer's instructions for inspection or correction of affected units.
The recalled product
- 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.
- Manufacturer
- WASATCH PHOTONICS
- Affected units
- 192
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes included in the model numbers.
Distribution
Distribution scope not specified by the agency.
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