Kowa Optimed Inc: Medical Device Recall in 2020 - (Recall #: Z-0636-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 3, 2020

Date Posted: December 23, 2020

Recall Number: Z-0636-2021

Event ID: 86737

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.

Status: Terminated

Product Quantity: N/A

Code Information:

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

Distribution Pattern:

US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.

Voluntary or Mandated:

Voluntary: Firm initiated