FDA Enforcement
Class II
Ongoing
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Recall: Z-1816-2024
·
Reported May 29, 2024
Enforcement
- Recall Number
- Z-1816-2024
- Event ID
- 94590
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- YAMAHA MOTOR CORPORATION
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- May 29, 2024
- Initiation Date
- April 17, 2024
- Classification Date
- May 20, 2024
- Address
- 3065 Chastain Meadows Pkwy, Marietta, GA, 30066-3324, United States
Description
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Reason
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.
Code Info
Model YRi-V, YSi-V, YSi-V(HS2)
Distribution
US Nationwide
Quantity
67