Z-0636-2021Class II

Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras...

Name: Z-0636-2021 Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras...
Creator: Kowa Optimed Inc
Published: 2020-11-03
License: https://open.fda.gov/license/

Kowa Pharmaceuticals America, Inc. / initiated 2020-11-03 / Terminated / root cause: software

FDA source

Kowa Optimed Inc began a recall of 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... on 2020-11-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0636-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-03
Posted: 2020-12-17
Terminated: 2022-12-06
Recalling firm: Kowa Pharmaceuticals America, 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.
Product code: NFJ System, Image Management, Ophthalmic
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.
Root cause tag: software
FDA 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 [email protected] " For specific information regarding the remote software update, please contact [email protected]
Distribution: US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0636-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17

Product code NFJ

K190056Class IIKOWA VK-2sKowa Co. Ltd. Chofu / cleared 2019-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)