Non-ablative Fractional Laser Systems, Model: WFB-01
FDA device recall Z-0555-2025 · posted 2024-12-05 · Open, Classified
Recall details
- Recalling firm
- WINGDERM ELECTRO-OPTICS LTD.
- 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)
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- ONG
- Distribution
- Worldwide Distribution
- Date initiated
- 2024-08-23
- Date posted
- 2024-12-05
- Location
- Beijing, Haidian District, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medical Non-Ablative Fractional Laser Systems (K192350) | Wingderm Electro-Optics , Ltd. | 2020-04-30 |