Recall Z-0555-2025 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
WINGDERM ELECTRO-OPTICS LTD.
Non-ablative Fractional Laser Systems, Model: WFB-01
| Date | Dec 5, 2024 (initiated Aug 23, 2024) |
| Status | Open, Classified |
| Reason | 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) |
| Root cause | Radiation Control for Health and Safety Act |
| 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. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192350 | Medical Non-Ablative Fractional Laser Systems Wingderm Electro-Optics , Ltd., Apr 30, 2020 |