Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Kowa VK-2s software Version 10.0.4.0 Recalled by Kowa Optimed Inc Due to It has been determined that the software distributed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Kowa Optimed Inc directly.
Affected Products
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
Quantity: N/A
Why Was This Recalled?
It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Kowa Optimed Inc
Kowa Optimed Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report