FDA recall Z-1816-2024

Product

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

US Nationwide

Key facts

Status

Ongoing

Initiation date

2024-04-17

Report date

2024-05-29

Voluntary/Mandated

FDA Mandated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2024