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U.S. Department of Health and Human Services

Class 2 Device Recall Optical Inspection System, YSi series

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  Class 2 Device Recall Optical Inspection System, YSi series see related information
Date Initiated by Firm April 17, 2024
Date Posted May 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1816-2024
Recall Event ID 94590
Product Classification Product incorporating certified class 1 data utility/peripheral laser product - Product Code RGA
Product Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Code Information Model YRi-V, YSi-V, YSi-V(HS2)
Recalling Firm/
Manufacturer		 YAMAHA MOTOR CORPORATION
3065 Chastain Meadows Pkwy
Marietta GA 30066-3324
For Additional Information Contact Brad Franklin
770-420-5825
Manufacturer 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.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
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 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/).
Quantity in Commerce 67
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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