FDA recall Z-0555-2025

WINGDERM ELECTRO-OPTICS LTD. · Class II · device

Product

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

Worldwide Distribution

Key facts

Status: Ongoing
Initiation date: 2024-08-23
Report date: 2024-12-11
Voluntary/Mandated: FDA Mandated
Location: Beijing, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0555-2025