| Date Initiated by Firm | August 17, 2026 |
| Date Posted | November 12, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0305-2027 |
| Recall Event ID |
100099 |
| |
| Product Classification |
Laser cutter - Product Code RFE
|
| Product | Product 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 |
| Action | A 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. |
| Distribution | U.S. |
| Total Product Life Cycle | TPLC 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.
|