Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PL

FDA device recall Z-1510-2024 · posted 2024-04-10 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DXN

Quantity affected

3547 units

Distribution

Global, US: NY, IL

Date initiated

2024-03-26

Date posted

2024-04-10

Location

Deerfield, IL