FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: 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
- Recalling firm
- Baxter Healthcare Corporation
- 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
- Status
- Open, Classified
- Initiated
- 2026-02-18
- Posted
- 2026-03-18
- Terminated
- not on file
- Reason
- Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
- Root cause
- Device Design
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HKO
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28