FDA Enforcement
Class II
Ongoing
Bodor P and C series laser cutting machines
Recall: Z-0768-2025
·
Reported January 29, 2025
Enforcement
- Recall Number
- Z-0768-2025
- Event ID
- 96035
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Jinan Bodor Cnc Machine Co Ltd
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- January 29, 2025
- Initiation Date
- December 19, 2024
- Classification Date
- January 18, 2025
- Address
- NO.1299, XINLUO AVE HI-TECH ZONE, Jinan, N/A, China
Description
Bodor P and C series laser cutting machines
Reason
Non-compliant laser products
Code Info
P series is 2421537-000 and C series is 2421612-000.
Distribution
US Nationwide Distribution
Quantity
269 units