Company: Kowa Optimed Inc
Date of Enforcement Report: 12/23/2020
Class II
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.
Recall Number: Z-0636-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Kowa Optimed Inc. on 11/3/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
NA
DISTRIBUTION
U.S. Nationwide