Device product
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Z-1816-2024
Product summary
- Event
- Event 94590
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 67
- Official record key
device-enforcement:Z-1816-2024
Official wording
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.
Code information: Model YRi-V, YSi-V, YSi-V(HS2)
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.