FDA-Device2020-12-23Class II
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.
Kowa Optimed Inc
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.
Sold states
US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
Affected count
N/A
Manufactured in
20001 S Vermont Ave, N/A, Torrance, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2021Don't want to check this manually?
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