Kowa VK-2s Software Recall for Potential Patient Data Deletion
Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential loss of patient data leading to delayed treatment, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Kowa Optimed Inc is recalling Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500, which is installed on Kowa nonmyd WX Retinal Cameras. The software is indicated for acquiring, displaying, and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
The recall was initiated because the software may delete patient information. Specifically, if multiple IDs are deleted at the same time, there is a potential for all patient information to be deleted. This data loss could result in a delay of treatment for patients.
The affected units were distributed nationwide in the United States, including in the states of NY, WA, TX, CT, MA, ID, IL, and MI. The recall covers specific serial numbers listed in the agency documentation. Healthcare facilities should contact Kowa Optimed Inc for instructions on how to address the software defect and protect patient data.
The recalled product
- 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.
- Manufacturer
- Kowa Optimed Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 32168900007
- 32168900008
- 32168900009
- 32168900010
- 32168900011
- 32168900019
- 32168900020
- 32168900021
- 32168900022
- 32168900025
- 32168900035
- 32168900036
- 32168900037
- 32168900044
- 32168900045
- 32169000052
- 32169000144
- 32169000145
- 32169000152
- 32169000153
Distribution
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