BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 17, 2024

    Recall

    Recall Number
    Z-1815-2024
    Event Number
    94590
    Firm
    YAMAHA MOTOR CORPORATION
    FEI Number
    3016567890
    Product Code
    RGA
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 17, 2024
    Posted
    May 20, 2024
    Address
    3065 Chastain Meadows Pkwy, Marietta, GA, 30066-3324

    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.

    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/).

    Distribution

    US Nationwide

    Quantity

    376