FDA-Device2026-03-25Class IIPROCESSING DEFECT
Welch Allyn Spot Vision Screener VS100 recalled for screen flickering risk
OTHERNationwide distribution
Stop using Welch Allyn Vision Screener VS100
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.
- 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
Hazard
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Sold states
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 count
59
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1573-2026More Baxter Healthcare Corporation recalls
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