Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall P and C Series

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall P and C Seriessee related information
Date Initiated by FirmDecember 19, 2024
Date PostedJanuary 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0768-2025
Recall Event ID 96035
Product Classification Laser cutter - Product Code RFE
ProductBodor P and C series laser cutting machines
Code Information P series is 2421537-000 and C series is 2421612-000.
Recalling Firm/
Manufacturer		 Jinan Bodor Cnc Machine Co Ltd
NO.1299, XINLUO AVE HI-TECH ZONE
Jinan China
Manufacturer Reason
for Recall		Non-compliant laser products
FDA Determined
Cause 2		Radiation 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) 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 Commerce269 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-