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.
What this means for you
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 SCREENER,W/CAS
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- power-cord-defect
- electrical-hazard
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:
- IL
- NY
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