Kowa Optimed Inc recalls Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product…

Recall date

November 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0636-2021

FDA classification

Class II

Brand / firm

Kowa Optimed Inc

Sold / distributed

US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.