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.
Reported: December 23, 2020 Initiated: November 3, 2020 #Z-0636-2021
Product 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 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.
Details
- Recalling Firm
- Kowa Optimed Inc
- Units Affected
- N/A
- Distribution
- US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
- Location
- Torrance, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Kowa Optimed Inc. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0636-2021.
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