Class 2 Device Recall Voalte Nurse Call

• Date Initiated by Firm: October 15, 2026
• Date Posted: November 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0446-2027
• Recall Event ID: 99982
• Product Classification: System, communication, powered - Product Code ILQ
• Product: Voalte Nurse Call, powered communication system used in healthcare facilities to transmit and receive patient calls, alerts, and related communications between patients and caregivers, Software Version 4.1.21x, 4.2.000, and 4.2.10x
• Code Information: UDI-DI software versions 4.1: 00887761979017 UDI-DI software versions 4.2: 00887761943131
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 1-847-9484770
• Manufacturer Reason for Recall: A software defect could delay staff assistance or emergency response.
• FDA Determined Cause: Software design
• Action: A Planned Maintenance Notification was sent to customers on 9/10/26. Baxter will be performing planned maintenance on the Precision Locating (PL) and Nurse Call integrated environment during the maintenance window noted below. This proactive maintenance is intended to optimize system performance and ensure continued reliability of PL badge communications within the Nurse Call ecosystem. Baxter personnel will perform all activities remotely and will monitor the environment throughout the maintenance window. Maintenance Window " Date: Friday, September 11, 2026 Time: 7:00 AM - 8:30 AM Eastern Time Expected Impact " Within the maintenance window, a brief interruption of up to 2 minutes may occur to locating-related services while system updates are applied. A temporary "Lost External Locating" system alert may appear on Nurse Call consoles and will disappear once service is restored. Status Board may be temporarily unavailable within this interruption timeframe. " No action is required from your team. An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/15/26 was sent to customers. Actions to be Taken by Customers 1. As a precaution, if you are deploying a new staff tag before upgrading to Nurse Call RTLS Connector v5.2.2, please contact Baxter. 2. Baxter will contact your facility to schedule installation of RTLS Connector version 5.2.2, which corrects this issue. This remote software update is estimated to take 30 minutes of downtime for Precision Locating at your facility. Baxter is finalizing the deployment schedule and will contact your facility to arrange installation by October 23, 2026. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply instruction sheet. Acknowledging receip
• Quantity in Commerce: 4 units
• Distribution: US Nationwide distribution in the states of Florida, Indiana, Louisiana, Nebraska, Nevada, New Mexico, and New York.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.