Lower riskMedical device recall · FDA · Published November 3, 2020
Kowa Retinal Cameras Software Version 10.0.4.0 May Delete Patient Data
Kowa Optimed recalls specific retinal camera software versions that could delete patient information if multiple IDs are deleted simultaneously, causing treatment delays.
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.
Take action
Contact the company
📍Recalling firmKowa Optimed Inc20001 S Vermont Ave · Torrance, CA 90502-1326
“Kowa Retinal Cameras Software Version 10.0.4.0 May Delete Patient Data.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63989-kowa-retinal-cameras-software-version-10-0-4-0-may. Based on FDA recall #Z-0636-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0636-2021%22&limit=1).
The FDA announced on November 3, 2020, that Kowa Optimed Inc is recalling Kowa VK-2s software Version 10.0.4.0 installed on Kowa nonmyd WX Retinal Cameras due to a hazard where patient information may be deleted. This error could result in a delay of treatment for patients.
According to the FDA, the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are deleted at the same time, there is a potential for all patient information to be deleted. This could result in delay of treatment.
How to tell if you have this one
Check if your Kowa nonmyd WX retinal camera has serial numbers listed: 32168900007 through 32169000168. The affected software version is 10.0.4.0.
Brand
Kowa
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your camera's software version by checking the device settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Idaho, Illinois, Massachusetts, Michigan, New York, Texas, Washington.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0636-2021 (November 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0636-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.