Non-ablative Fractional Laser Systems recall: Software Issue
Non-ablative Fractional Laser Systems, Model: WFB-01
Why was Non-ablative Fractional Laser Systems 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
- Product
- Non-ablative Fractional Laser Systems, Model: WFB-01
- Recalling firm
- WINGDERM ELECTRO-OPTICS LTD.
- Distribution
- Worldwide Distribution
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)