FDA Medical Device Recalls (openFDA)
WINGDERM ELECTRO-OPTICS LTD.: Non-ablative Fractional Laser Systems, Model: WFB-01
- Recall number
- Z-0555-2025
- Recalling firm
- WINGDERM ELECTRO-OPTICS LTD.
- Product
- Non-ablative Fractional Laser Systems, Model: WFB-01
- Status
- Open, Classified
- Initiated
- 2024-08-23
- Posted
- 2024-12-05
- Terminated
- not on file
- 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.
- Quantity
- not on file
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
- 510(k) numbers
- ["K192350"]
- PMA numbers
- not on file
- Product code
- ONG
- Firm FEI
- 3014310779
- Firm city
- Beijing
- Firm state
- Haidian District
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28