Recall Z-0636-2021— Kowa Optimed Inc
Class II · Terminated
Class II FDA medical device recall by Kowa Optimed Inc, initiated 2020-11-03, terminated 2022-12-06. It names one FDA 510(k) clearance: K190056. 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.. 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..
- Recalling firm
- Kowa Optimed Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-03
- Terminated
- 2022-12-06
- Firm location
- Torrance, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.