Non-ablative Fractional Laser Systems, Model: WFB-01
FDA Recall Z-0555-2025 · Posted 2024-12-05
Recalling FirmWINGDERM ELECTRO-OPTICS LTD.
Recall StatusOpen, Classified
Product CodeONG
Date Initiated2024-08-23
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)
Firm Action
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
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.