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.
FDA Recall Z-0636-2021 · Posted None
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Recalling FirmKowa Optimed Inc
Recall StatusTerminated
Product CodeNFJ
Date Initiated2020-11-03
Date Terminated2022-12-06
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.
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]
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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