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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 17, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0305-2027
Recall Event ID 100099
Product Classification Laser cutter - Product Code RFE
ProductProduct Series: CMH Series Main Model Involved: CMH1530-C-A Laser Power Range: 1.5-6 kW
Code Information None provided
FEI Number 3013269066
Recalling Firm/
Manufacturer
GD HAN'S YUEMING LASER GROUP CO. LTD.
NO.28 INDUSTRIAL EAST ROAD, SONGSHAN LAKE
HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE
DONGGUAN China
Manufacturer Reason
for Recall
The rear service/maintenance doors of certain early CMH1530-C-A laser cutting machines were fitted only with key-operated mechanical locks and were not equipped with laser safety interlock devices.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
ActionA letter dated 08/17/2026, "Product Defect Notification letter" was sent to customers. Corrective-Action Process. The company will perform field corrective action on all confirmed affected equipment in the U.S. market.
DistributionU.S.
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.
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