FDANovember 3, 2020device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
kowa optimedkowa
UPCs
321689000073216890000832168900009321689000103216890001132168900019321689000203216890002132168900022321689000253216890003532168900036
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →