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Z-0768-2025Class II

Bodor P and C series laser cutting machines

Jinan Bodor Cnc Machine Co Ltd / initiated 2024-12-19 / Open, Classified

Jinan Bodor Cnc Machine Co Ltd began a recall of Bodor P and C series laser cutting machines on . FDA classified it as Class II and gives the reason as "Non-compliant laser products". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0768-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Jinan Bodor Cnc Machine Co Ltd
Product
Bodor P and C series laser cutting machines
Product code
RFE Laser Cutter
Reason for recall
Non-compliant laser products
FDA root cause
Radiation Control for Health and Safety Act
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.
Quantity in commerce
269 units
Distribution
US Nationwide Distribution
Product codes and lots
P series is 2421537-000 and C series is 2421612-000.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0768-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0768-2025Class IIOngoingFDA Mandated