FDA-Device2026-03-25Class IIPROCESSING DEFECT
Welch Allyn Spot Vision Screener VS100 recalled for screen flickering risk
What this means
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
The agency's original wording
Hazard
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Intended for
All ages
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
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- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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