Non-ablative Laser System WFB-01 (WINGDERM) – Software Bug (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Non-ablative Fractional Laser Systems, Model: WFB-01
Brand
WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China
Lot Codes / Batch Numbers
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Products Sold
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China is recalling Non-ablative Fractional Laser Systems, Model: WFB-01 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026