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WINGDERM ELECTRO-OPTICS LTD. recalls Non-ablative Fractional Laser Systems, Model: WFB-01
Recalled December 11, 2024 · FDA recall Z-0555-2025 · WINGDERM ELECTRO-OPTICS
Hazard
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) · FDA Class II
Sold at
Worldwide Distribution
Description
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)
Product
Non-ablative Fractional Laser Systems, Model: WFB-01
Manufacturer(s)
WINGDERM ELECTRO-OPTICS LTD.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →