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 Insight

This FDA Devices action (record #Z-0636-2021) was formally reported on December 23, 2020, with the manufacturer initiating the action on November 3, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Kowa Optimed Inc is listed as the recalling firm, operating out of Torrance, CA. Federal records indicate N/A units are affected.

The documented reason for this recall is: 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 t… Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.