Z-1573-2026 Class II Ongoing
FDA device recall Z-1573-2026 was initiated by Baxter Healthcare Corporation on Feb 18, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 59.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 25, 2026
- Initiation Date
- Feb 18, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59
Product 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 for Recall
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Distribution Pattern
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.
Code Information
Lot Code: " Product Code: HKO " Version or Model: 901029 " Catalog Number: VS100 " Company Name: WELCH ALLYN, INC. " Primary DI Number: 00732094214154 " Packaging DI Number: 00732094212228 " Device Description: VS100 UDI BASE UNIT " Software version: 3.2.0.1 " Serial Numbers: Refer to attached Affected Product Table
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1573-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026