# FDA recall Z-0636-2021

> **Kowa Optimed Inc** · Class II · device recall initiated 2020-11-03.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0636-2021
- **Recalling firm:** Kowa Optimed Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-03
- **Report date:** 2020-12-23
- **Termination date:** 2022-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Torrance, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2021

## Citation

> AI Analytics. FDA recall Z-0636-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0636-2021. Source: US FDA. Licensed CC0.

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