Kowa VK-2s Software (Kowa Optimed) – Patient Data Deletion (2020)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Kowa Optimed Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Kowa Optimed Inc is recalling Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retina due to It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 11/03/2020 Kowa Company mailed a "Urgent Medical Device Recall letter to all affected consignees. In addition to informing consignees about the recalled software, the firm asked consignees to take the following actions: 1. The service team at Kowa will contact each customer and remove version 10.0.4.0. on all workstations and provide version 10.0.4.100. A CD of version 10.0.4.100 will be mailed to each customer, but the removal and software update will be performed remotely. Other Information: 2. Complete the Medical Device Acknowledgement and receipt form and fax completed response form to : 310-327-4177 ATTN: Benjamin Rhodes or mail to: Kowa American Corporation, 20001 South Vermont Avenue, Torrance, CA 90502. 3. " For more information, please contact Benjamin Rhodes at brhodes@kowa.com " For specific information regarding the remote software update, please contact service@kowa.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026