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.
Check against the official notice below — it lists the full affected range.
Kowa Optimed Inc. is recalling Kowa VK-2s software Version 10.0.4.0 installed on Kowa nonmyd WX Retinal Cameras due to a defect that may delete patient information. The software issue occurs when multiple patient IDs are deleted simultaneously, which could result in deletion of all patient information and potentially delay treatment. The affected cameras were distributed nationwide, including in New York, Washington, Texas, Connecticut, Massachusetts, Idaho, Illinois, and Michigan, with specific serial numbers ranging from 32168900007 through 32169000168.
The record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI. Quantity: N/A Lot/code info: Serial Numbers: 32168900007, 32168900008, 32168900009, 32168900010, 32168900011, 32168900019, 32168900020, 32168900021, 32168900022, 32168900025, 32168900035, 32168900036, 32168900037, 32168900044, 32168900045, 32169000052, 32169000144, 32169000145, 32169000152, 32169000153, 32169000166, 32169000167, 32169000168
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.