Reported Dec 23, 2020 · Terminated
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product…
Kowa Optimed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kowa Optimed Inc · 20001 S Vermont Ave · Torrance, CA · 90502-1326
Is this the product you have?
- Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd
- WX Retinal Cameras - Product Usageis indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras
- Lot codes and dates
- Serial Numbers
3216890000732168900008321689000093216890001032168900011321689000193216890002032168900021321689000223216890002532168900035321689000363216890003732168900044321689000453216900005232169000144321690001453216900015232169000153321690001663216900016732169000168
- Serial Numbers
- Amount recalled
- N/A
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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