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U.S. Department of Health and Human Services

Class 2 Device Recall Lazervida 10W Diode Laser Cutter and Engraver (Model LVD1)

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 Class 2 Device Recall Lazervida 10W Diode Laser Cutter and Engraver (Model LVD1)see related information
Date Initiated by FirmFebruary 19, 2025
Date PostedJune 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1878-2025
Recall Event ID 96935
Product Classification Laser marker or engraver, industrial or commercial - Product Code RHK
ProductLazervida 10W diode laser cutter and engraver with Lazervida shield.
Code Information None.
FEI Number 3015156297
Recalling Firm/
Manufacturer		 Flux Technology Inc.
9 F; No. 465 Zhongxiao E. Rd., Sec. 6
Nangang District
Taipei City Taiwan
For Additional Information Contact
2-26513171
Manufacturer Reason
for Recall		Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.
ActionCustomer Notification Letters were sent informing customers of Noncompliance, instructions of installation process and safety enhancement kit to be sent. Flux also provided customers with contact info for any questions or require assistance, Flux customer support team is available at support@flux3dp.com.
Quantity in Commerce91
DistributionUS
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.
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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