Baxter Healthcare Corporation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Baxter Healthcare Corporation is recalling Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISIO due to Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Baxter issued an Urgent Medical Device Correction notice to its consignees on 03/26/2024 via USPS, first class mail. The notice explained the issue, hazard, and provided the following: Actions to be taken by customers: 1. Healthcare providers may continue to use the non-compliant power cords, but if any fraying or damage is observed, users should NOT make physical contact with the cord and discard the power cord immediately. 2. Healthcare providers should regularly inspect the power cords for fraying or other damage. 3. Once Baxter has replacement power cords, a follow-up notification will be sent with additional instructions on how to request replacement power cords. 4. Customers will be asked to acknowledge receipt of the Urgent Medical Device Correction notification by responding on our customer portal. 5. If the product has been distributed to other facilities or departments within the institution, customers will be asked to forward a copy of the Urgent Medical Device Correction notification to them. 6. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, they will be asked to notify their customers of this Urgent Medical Device Correction according to their customary procedures and check the associated box on the customer portal.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, NY
Page updated: Jan 10, 2026