Recall Z-0636-2021 ยท NFJ System, Image Management, Ophthalmic
Kowa Optimed Inc
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.
| Date | Nov 3, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| 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 |
| Distribution | US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190056 | KOWA VK-2s Kowa Co. Ltd. Chofu, Feb 12, 2019 |