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
FDA Recall Z-1815-2024 · Posted 2024-05-20
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Recalling FirmYAMAHA MOTOR CORPORATION
Recall StatusOpen, Classified
Product CodeRGA
Date Initiated2024-04-17
Product Quantity376
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.
Firm Action
Yamaha Motor Robotics has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label at the time they were shipped. Our records indicate that you have received one or more of the products affected by this problem. In this packet, we are providing you with the missing labels and instructions on their placement to correct this matter. These actions are being taken at no expense to you.
Corrective Action Instructions:
1. Please locate the certification labels provided in this packet. (If you need more, please contact the Corrective Action Plan Coordinator at [email protected] or (770) 420-5825 and we will send you more at no expense to you).
2. Following the label placement instructions for your product found below, affix the label in the indicated position.
3. Download the revised user manuals from the "YAMAHA Surface Mounter Support & Service" website (https://www.yamaha-smtservice.net/en/).
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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