Torrance, CA, United States
Kowa Optimed Inc recalls
1 recall recorded since 2018, most recently on 3 November 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 November 2020
- Terminated
- 6 December 2022
- 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.
- Distribution
- US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0636-2021
- 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-m
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.