FDA Medical Device Recalls (openFDA)
Jinan Bodor Cnc Machine Co Ltd: Bodor P and C series laser cutting machines
- Recall number
- Z-0768-2025
- Recalling firm
- Jinan Bodor Cnc Machine Co Ltd
- Product
- Bodor P and C series laser cutting machines
- Status
- Open, Classified
- Initiated
- 2024-12-19
- Posted
- 2025-01-18
- Terminated
- not on file
- Reason
- Non-compliant laser products
- 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
- 269 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- P series is 2421537-000 and C series is 2421612-000.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFE
- Firm FEI
- 3008620561
- Firm city
- Jinan
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28