WINGDERM ELECTRO-OPTICS LTD. recalls Non-ablative Fractional Laser Systems, Model: WFB-01

Recall date

August 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0555-2025

FDA classification

Class II

Brand / firm

WINGDERM ELECTRO-OPTICS LTD.

Sold / distributed

Worldwide Distribution

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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Non-ablative Fractional Laser Systems, Model: WFB-01