FDA Enforcement
Class II
Ongoing
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD
Recall: Z-1815-2024
·
Reported May 29, 2024
Enforcement
- Recall Number
- Z-1815-2024
- 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
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD
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
YR series Model YRM20-1, YRM20-2 YS series Model YC8, YSM10 YSM20-1, YSM20-2, YSM20W-2 YSM20R-1, YSM20R-2, YSM20R(SV)-1, YSM20R(SV)-2 i-PULSE series Model S10, S20, M20 Sigma series Model SIGMA-G5S2
Distribution
US Nationwide
Quantity
376