Non-ablative Fractional Laser Systems, Model: WFB-01
This recall is currently active, issued December 5, 2024. It was issued by Wingderm Electro-Optics Ltd. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China.
- Recall Initiated
- August 23, 2024
- Posted
- December 5, 2024
- Recall Number
- Z-0555-2025
- Official Source
- View on FDA website ↗
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
Lot / Code Info
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Root 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.