ClearanceBrief
Recall Z-0768-2025 ยท RFE Laser Cutter

Jinan Bodor Cnc Machine Co Ltd

Bodor P and C series laser cutting machines

DateJan 18, 2025 (initiated Dec 19, 2024)
StatusOpen, Classified
ReasonNon-compliant laser products
Root causeRadiation Control for Health and Safety Act
ActionBodor 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) Saf
Quantity269 units
DistributionUS Nationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.