Recall Z-0556-2025
Wingderm Electro-Optics Ltd. · initiated August 23, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Diode Laser Hair Removal model: WLA-01
Codes / lots: F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Reason for recall
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
The firm sent a notification letter to the relevant distribution on June 6, 2024. Products sold before August 23, 2022, will require a software version upgrade to F1-B-1.1.012 or Higher.
Details
- Recall number
- Z-0556-2025
- Initiated
- August 23, 2024
- Posted by FDA
- December 5, 2024
- Product code
- GEX – Powered Laser Surgical Instrument
- Distribution
- Worldwide Distribution
- Recalling firm
- Wingderm Electro-Optics Ltd., Beijing, Haidian Di
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0555-2025 Class II | Non-ablative Fractional Laser Systems, Model: WFB-01Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All… | 08/23/2024Open, Classified |