YAMAHA MOTOR CORPORATION: Medical Device Recall in 2024 - (Recall #: Z-1815-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
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
Class II
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.
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
US Nationwide
FDA Mandated
