medical Class II Updated 2024-12-11

WINGDERM ELECTRO-OPTICS LTD. recalls Non-ablative Fractional Laser Systems, Model: WFB-01

Recalled Product

Non-ablative Fractional Laser Systems, Model: WFB-01


Hazard / Issue

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)

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
View official government recall

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