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U.S. Department of Health and Human Services

Class 2 Device Recall Kowa VK2s software

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  Class 2 Device Recall Kowa VK2s software see related information
Date Initiated by Firm November 03, 2020
Create Date December 17, 2020
Recall Status1 Terminated 3 on December 06, 2022
Recall Number Z-0636-2021
Recall Event ID 86737
510(K)Number K190056  
Product Classification System, image management, ophthalmic - Product Code NFJ
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.
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
Recalling Firm/
Manufacturer		 Kowa Optimed Inc
20001 S Vermont Ave
Torrance CA 90502-1326
For Additional Information Contact Benjamin Rhodes
310-327-1913
Manufacturer 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.
FDA Determined
Cause 2		 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
Distribution US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NFJ and Original Applicant = KOWA Co. Ltd. CHOFU
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