Non-ablative Fractional Laser Systems WFB-01: Software Bug and Labeling Issues Recalled
Non-ablative Fractional Laser Systems Model WFB-01 are recalled due to a software bug affecting 6 units sold to US customers before August 23, 2022, and labeling non-compliances affecting 22 units sold to US customers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries or hospitalizations. The software defect's specific consequences are unspecified, and labeling non-compliance is a regulatory documentation issue. Per the rubric, Class II recalls with unspecified hazards and no reported illness fall under Moderate severity.
Plain-English summary
The Non-ablative Fractional Laser System Model WFB-01, manufactured by Wingderm Electro-Optics Ltd., is being recalled due to software defects and labeling non-compliances discovered in units distributed to US customers.
Six units of the WFB-01 model sold to US customers before August 23, 2022 contain a software bug. Additionally, 22 WFB-01 units sold to US customers have been identified as having labeling non-compliances. The specific technical nature of the software defect and the exact labeling violations are not detailed in this recall notice.
Customers who have purchased the WFB-01 model should verify whether their unit may be affected based on the serial number and lot codes (F7201110001, F1210910001, F1210910002, F7211210001, F7226110002, F7227110001) and purchase date. Those with units sold before August 23, 2022 or units suspected of having labeling issues should contact Wingderm Electro-Optics Ltd. for remediation instructions. Additional information is available at the FDA recall page: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-0555-2025
The recalled product
- Product
- Non-ablative Fractional Laser Systems, Model: WFB-01
- Manufacturer
- WINGDERM ELECTRO-OPTICS LTD.
- Category
- Medical Device — Laser System
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by WINGDERM ELECTRO-OPTICS LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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