Recall archive / FDA device enforcement
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE... — FDA record Z-1510-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 3547 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1510-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Global, US: NY, IL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 17, 2024
- Recall initiation date
- Mar 26, 2024
- Center classification date
- Apr 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.