Home / Recalls / WINGDERM ELECTRO-OPTICS LTD. / Z-0555-2025

Z-0555-2025 Class II Ongoing

Recalled by WINGDERM ELECTRO-OPTICS LTD. — Beijing

Recall Details

Product Type: Devices
Report Date: December 11, 2024
Initiation Date: August 23, 2024
Termination Date: N/A
Voluntary/Mandated: FDA Mandated
Product Quantity

Product Description

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

Reason for Recall

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)

Distribution Pattern

Worldwide Distribution

Code Information

F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001