Z-0636-2021 Class II Terminated
FDA device recall Z-0636-2021 was initiated by Kowa Optimed Inc on November 3, 2020 and is designated Class II. 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 pa… The recall status is terminated (terminated December 6, 2022). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 3, 2020
- Termination Date
- December 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.
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