Yamaha Optical Inspection Systems Recalled for Missing Laser Safety Certification Label
Yamaha Motor Corporation is recalling 67 Optical Inspection System units (models YSi-V, YSi-V(HS2), YRi-V) distributed nationwide for not bearing the required laser safety certification label.
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: This is a Class II recall of a laser product lacking the required federal safety certification label. Laser products present inherent risk of eye damage from radiation exposure. While no injuries have been reported, the missing certification means users may not be properly informed of hazards, justifying a High severity rating under the rubric criterion for risk-of-harm products with no reported injury.
Plain-English summary
Yamaha Motor Corporation is recalling 67 units of its Optical Inspection System, specifically models YSi-V, YSi-V(HS2), and YRi-V. The units were distributed nationwide.
The laser products do not comply with the federal laser safety standard 21 C.F.R. § 1010.2 because they do not bear the required certification label. This label is mandated by federal regulation to ensure users are aware of laser hazards and required safety precautions.
No injuries or illnesses have been reported related to this issue.
The recalled product
- Product
- Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
- Manufacturer
- YAMAHA MOTOR CORPORATION
- Category
- Other — Laser Equipment
- Affected units
- 67
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 (3)
- Model YRi-V
- YSi-V
- YSi-V(HS2)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by YAMAHA MOTOR CORPORATION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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