Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
This recall is currently active, issued May 20, 2024. It was issued by Yamaha Motor Corporation.
- Company
- Yamaha Motor Corporation
- Recall Initiated
- April 17, 2024
- Posted
- May 20, 2024
- Recall Number
- Z-1816-2024
- Quantity
- 67
- Firm Location
- Marietta, GA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide
Lot / Code Info
Model YRi-V, YSi-V, YSi-V(HS2)
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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 robotics_service@yamaha-motor.com 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/).