Device product
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
Z-1815-2024
Product summary
- Event
- Event 94590
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 376
- Official record key
device-enforcement:Z-1815-2024
Official wording
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 information: 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 pattern: US Nationwide
Derived failure modes
-
Unknown
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.