Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
FDA Recall #Z-1816-2024 — Class II — April 17, 2024
Product Description
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Reason for Recall
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
Recalling Firm
YAMAHA MOTOR CORPORATION — Marietta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
67
Distribution
US Nationwide
Code Information
Model YRi-V, YSi-V, YSi-V(HS2)
Status
Ongoing
Voluntary / Mandated
FDA Mandated