Welch Allyn Spot Vision Screener VS100 recalled for screen flickering risk
The Welch Allyn Spot Vision Screener VS100 (software version 3.2.0.1) may display an unintended flickering screen due to a software issue. Flickering lights can trigger seizures in people who are photosensitive.
From the FDA notice · Read the official notice ↗ · All Baxter recalls
What to do
- Stop using the device immediately if you have one
- Contact Welch Allyn or your equipment supplier for a software update or replacement
- Do not use the device on patients with known photosensitivity or seizure disorders
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 59
- Illnesses reported
- None reported
- Manufactured in
- 1 Baxter Pkwy, N/A, Deerfield, IL, United States
- Classification
- Class II
- Recall number
- Z-1573-2026
In the FDA's words
- Description
- Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals. Lot Code: " Product Code: HKO " Version or Model: 901029 " Catalog Number: VS100 " Company Name: WELCH ALLYN, INC. " Primary DI Number: 00732094214154 " Packaging DI Number: 00732094212228 " Device Description: VS100 UDI BASE UNIT " Software version: 3.2.0.1 " Serial Numbers: Refer to attached Affected Product Table Distribution: Worldwide - US Nationwide distribution in the states of AZ, CO, IL, IN, KS, MA, NE, NJ, NM, NY, PA, SC, TX, VA and the countries of Colombia and India. Affected quantity: 59
- Hazard
- Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
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