BEUDAMED
    FDA Recall Open, Classified

    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: Z-1573-2026 · Initiated February 18, 2026

    Recall

    Recall Number
    Z-1573-2026
    Event Number
    98439
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    HKO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 18, 2026
    Posted
    March 18, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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

    Reason

    Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.

    Action

    On February 18, 2026, the firm notified consignees via Urgent Medical Device Recall letters. Users were instructed to immediately locate, isolate, and stop using the listed affected products. Customers should contact Baxter Technical Support to arrange for the return and correction of their impacted device. Baxter may provide a loaner device upon request while your device is being upgraded and serviced. Distributors should return unopened products in inventory for credit. If affected product was further distributed, the distributor should conduct a consumer-level recall.

    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.

    Quantity

    59