The Recall Desk
ModerateFDA (Devices)·Z-0555-2025·Announced 2024-12-11

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.

What this means for you

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
Hazard
  • software-defect
  • mis-labeling

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.

Related recalls

Same category