Agency classClass IIOur severity:High FDA (Devices)·Z-1510-2024·Announced 2024-04-17

Hillrom Welch Allyn Spot Vision Screener recalled for power cord insulation defect

Hillrom Welch Allyn Spot Vision Screener VS100 units recalled due to power cord insulation that does not meet electrical safety standards. The affected devices may pose an electrical hazard to users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II medical device recall with a power cord insulation defect that poses a potential electrical hazard. No injuries or illnesses have been reported, but the defect represents a risk-of-harm condition that could affect user safety if devices remain in use.

Plain-English summary

The Hillrom Welch Allyn Spot Vision Screener VS100, manufactured by Baxter Healthcare Corporation, is being recalled due to a power cord insulation defect. The power cord insulation on affected units does not meet country-specific requirements and international electrical standards.

Approximately 3,547 units have been distributed globally, including to locations in New York and Illinois in the United States. The affected models include units sold with and without cases, as well as power supply sets, distributed across multiple electrical plug configurations.

Improper power cord insulation may create an electrical hazard. Baxter Healthcare Corporation is advising users to discontinue use of the affected devices immediately and return them for replacement or repair. Customers should contact Baxter Healthcare Corporation for more information regarding the recall and to arrange for replacement units.

The recalled product

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…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Vision screening / Diagnostic equipment
Hazard: power-cord-defect
electrical-hazard
Affected units: 3,547

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · power cord defect