Summary
The FDA issued a Class II for Non-ablative Fractional Laser Systems, Model: WFB-01 by WINGDERM ELECTRO-OPTICS LTD.. 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.
Details
Source
Device Recall
External ID
Z-0555-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
Non-ablative Fractional Laser Systems, Model: WFB-01
Lot/Code Info: F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
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)
Distribution
Worldwide Distribution
Type: FDA Mandated
Recall Initiated: 2024-08-23
Company
Beijing
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
WINGDERM ELECTRO-OPTICS LTD. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WINGDERM ELECTRO-OPTICS LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WINGDERM ELECTRO-OPTICS LTD. have FDA actions?
WINGDERM ELECTRO-OPTICS LTD. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0555-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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