Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0636-2021

November 03, 2020

Class II

Product summary

Firm
Kowa Optimed Inc
Event
Event 86737
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0636-2021

Official wording

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.

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

Distribution pattern: US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software distributed with the retinal camera may