Baxter Healthcare Corporation: Medical Device Recall in 2023 - (Recall #: Z-2006-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

Product Classification:

Class II

Date Initiated: May 19, 2023

Date Posted: July 5, 2023

Recall Number: Z-2006-2023

Event ID: 92300

Reason for Recall:

Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

Status: Ongoing

Product Quantity: 8 software versions

Code Information:

UDI/DI 00887761995086, Software Versions: 4.0: 4.0.000, 4.0.100, 4.0.110, 4.0.200, 4.0.300, 4.0.301, 4.0.400, 4.0.401

Distribution Pattern:

US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.

Voluntary or Mandated:

Voluntary: Firm initiated