Z-1816-2024 Class II Ongoing
FDA device recall Z-1816-2024 was initiated by YAMAHA MOTOR CORPORATION on April 17, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 67.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 67
Product Description
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
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 Pattern
US Nationwide
Code Information
Model YRi-V, YSi-V, YSi-V(HS2)