FDAFDA · Food and drugs·Recall number Z-1510-2024
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPOT VISION SCREENER,W/CASE,PLUG4/UK, VS100S-4; f) SPOT VISION SCREENER,W/CASE,PLUG7/SA, VS100S-7; g) SPOT VISION SCREENER W/CASE, BRAZIL, VS100S-Z; h) SPOT VS POWER SUPPLY SET/PLUG2/EUR, 106364; i) SPOT VS POWER SUPPLY SET/PLUG4/UK, 106366; j) SPOT VS POWER SUPPLY SET/PLUG7/SA, 106368; for use during vision screening
Published April 17, 2024 · Recall initiated: March 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Global, US: NY, IL
- Lot
- a) VS100-2, UDI/DI 732094224214; b) VS100-4, UDI/DI 732094224191; c) VS100-7, UDI/DI 732094224092; d) VS100S-2, UDI/DI 732094224177; e) VS100S-4, UDI/DI 732094224153; f) VS100S-7, UDI/DI 732094224085; g) VS100S-Z, UDI/DI 732094294217; h) 106364, UDI/DI 732094246964; i) 106366, UDI/DI 732094319927; j) 106368, UDI/DI 732094248692
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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