Non-ablative Fractional Laser Systems, Model: WFB-01
Reported: December 11, 2024 Initiated: August 23, 2024 #Z-0555-2025
Product Description
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)
Details
- Recalling Firm
- WINGDERM ELECTRO-OPTICS LTD.
- Distribution
- Worldwide Distribution
- Location
- Beijing
Frequently Asked Questions
What product was recalled? ▼
Non-ablative Fractional Laser Systems, Model: WFB-01. Recalled by WINGDERM ELECTRO-OPTICS LTD..
Why was this product 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)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0555-2025.
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