Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

FDA device recall Z-1816-2024 · posted 2024-05-20 · Open, Classified

Recall details

Recalling firm

YAMAHA MOTOR CORPORATION

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.

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/).

Root cause

Radiation Control for Health and Safety Act

Status

Open, Classified

Product code

RGA

Quantity affected

67

Distribution

US Nationwide

Date initiated

2024-04-17

Date posted

2024-05-20

Location

Marietta, GA