FDA Medical Device Recalls (openFDA)
Kowa Optimed Inc: 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 number
- Z-0636-2021
- Recalling firm
- Kowa Optimed Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-11-03
- Posted
- not on file
- Terminated
- 2022-12-06
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- not on file
- Distribution
- US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K190056"]
- PMA numbers
- not on file
- Product code
- NFJ
- Firm FEI
- 2080939
- Firm city
- Torrance
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28