FDA Recall Open, Classified

Bodor P and C series laser cutting machines

Recall: Z-0768-2025 · Initiated December 19, 2024

Recall

Recall Number
Z-0768-2025
Event Number
96035
Firm
Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China
FEI Number
3008620561
Product Code
RFE
Status
Open, Classified
Root Cause
Radiation Control for Health and Safety Act
Initiated
December 19, 2024
Posted
January 18, 2025

Description

Bodor P and C series laser cutting machines

Reason

Non-compliant laser products

Action

Bodor Laser will write to inform all dealers and purchaser that the [P or C] series product(s) you purchased from Bodor may require an update. Specifically, Bodor will take the following steps: 1. For correction of defective products related to 21 CFR 1040.10(f)(1) Protective Housing, Bodor will perform inspections and installations of vision-based collision detection function to ensure that when an operator enters the protective enclosure, the equipment automatically detects their presence and stops operating. 2. For correction of defective products related to 21 CFR 1040.10(f)(2) Safety Interlocks, Bodor will perform inspections and installations of safety interlocks on the side doors to ensure that the equipment automatically stops when the side doors are The inspection, installation and/or repair, and testing may be conducted at your location. Bodor will remedy the defect or bring the product into compliance at no charge. Bodor will contact you to arrange a mutually agreeable time for the update operations to take place.

Distribution

US Nationwide Distribution

Quantity

269 units