Company: Baxter Healthcare Corporation
Date of Enforcement Report: 3/18/2026
Class: II
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.
Recall Number:
Z-1573-2026
REASON:
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
RECALLING FIRM/MANUFACTURER:
Baxter Healthcare Corporation
VOLUME:
59
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.
