BEUDAMED
    FDA Recall Terminated

    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: Z-0636-2021 · Initiated November 3, 2020

    Recall

    Recall Number
    Z-0636-2021
    Event Number
    86737
    Firm
    Kowa Optimed Inc
    FEI Number
    2080939
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 3, 2020
    Terminated
    December 6, 2022
    Address
    20001 S Vermont Ave, Torrance, CA, 90502-1326

    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.

    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.

    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.