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Kowa Optimed Inc recalls Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product
Recalled December 23, 2020 · FDA recall Z-0636-2021 · Kowa Optimed
Hazard
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. · FDA Class II
Units
N/A
Sold at
US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
Description
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.
Product
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.
Manufacturer(s)
Kowa Optimed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →