Wingderm Electro-Optics LTD. has recalled its Non-ablative Fractional Laser Systems (Model WFB-01) and Diode Laser Hair Removal systems (Model WLA-01). The recall affects 6 units of the WFB-01 model sold before August 23, 2022, which contain a software bug, along with 22 units of WFB-01 and all WLA-01 units sold in the U.S. that have labeling non-compliances. No incidents or injuries have been reported to date.
A software bug in the fractional laser systems could cause the device to operate incorrectly or produce unintended laser output. Additionally, improper labeling may lead to misuse or safety hazards for both patients and medical operators.
Recall affects 6 units for software bug and 22 units for labeling non-compliance.
All systems sold to US customers are found to have labeling non-compliances.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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