Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software

FDA device recall Z-1573-2026 · posted 2026-03-18 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

HKO

Quantity affected

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.

Date initiated

2026-02-18

Date posted

2026-03-18

Location

Deerfield, IL