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Open, Classified

Bodor P and C series laser cutting machines

FDA Recall Z-0768-2025 · Posted 2025-01-18

Recall StatusOpen, Classified
Product CodeRFE
Date Initiated2024-12-19
Product Quantity269 units

Reason for Recall

Non-compliant laser products

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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