Reported Dec 11, 2024 · Ongoing
Non-ablative Fractional Laser Systems, Model: WFB-01
Wingderm Electro-Optics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WINGDERM ELECTRO-OPTICS LTD. · Room 312 · Beijing · N/A
Is this the product you have?
- Non-ablative Fractional Laser Systems
- ModelWFB-01
- Lot codes and dates
- F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
This product could cause temporary or reversible health problems — stop using it.
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