FDA Medical devices recall ·
Non-ablative Fractional Laser Systems, Model: WFB-01 recall
- Recall number
- Z-0555-2025
- Date
- (initiated August 23, 2024)
- Company / brand
- Wingderm Electro-Optics Ltd.
Room 312, Beijing, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Software
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Non-ablative Fractional Laser Systems, Model: WFB-01
Why was it 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)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution
Worldwide Distribution
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0555-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.