FDA Medical Device Recalls (openFDA)
YAMAHA MOTOR CORPORATION: 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 number
- Z-1815-2024
- Recalling firm
- YAMAHA MOTOR CORPORATION
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2024-04-17
- Posted
- 2024-05-20
- Terminated
- not on file
- 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.
- Root cause
- 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
- 376
- Distribution
- US Nationwide
- Lot, serial or model codes
- YR series Model YRM20-1, YRM20-2 YS series Model YC8, YSM10 YSM20-1, YSM20-2, YSM20W-2 YSM20R-1, YSM20R-2, YSM20R(SV)-1, YSM20R(SV)-2 i-PULSE series Model S10, S20, M20 Sigma series Model SIGMA-G5S2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RGA
- Firm FEI
- 3016567890
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28