Recall Z-1815-2024— YAMAHA MOTOR CORPORATION
Class II · Ongoing
Class II FDA medical device recall by YAMAHA MOTOR CORPORATION, initiated 2024-04-17. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- YAMAHA MOTOR CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-17
- Firm location
- Marietta, GA, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.