Recall Z-1816-2024— YAMAHA MOTOR CORPORATION
Class II · Ongoing
Class II FDA medical device recall by YAMAHA MOTOR CORPORATION, initiated 2024-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V. 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..
- Recalling firm
- YAMAHA MOTOR CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-17
- Firm location
- Marietta, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.