Agency classClass IIOur severity:High FDA (Devices)·Z-2006-2023·Announced 2023-07-05

Voalte Patient Safety software may fail to alert caregivers of safety changes

Baxter's Voalte Patient Safety software may permanently stop sending caregiver alerts for critical patient protocols like bed exit and siderail changes. Affected versions V4.0.000 through V4.0.401 are used with Centrella Beds.

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 an FDA Class II medical device recall with a significant failure mode—the software may suppress critical caregiver alerts—but no injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products without reported injury are rated High.

Plain-English summary

Baxter Healthcare Corporation is recalling Voalte Patient Safety software (Part Number 4.0, software versions V4.0.000 through V4.0.401) used with Centrella Beds. This software monitors patient safety protocols and alerts caregivers to changes in patient settings and bed conditions.

Baxter identified a potential risk where the software's safety monitoring and bed exit monitoring features may enter a permanent state of alert suppression. When this occurs, a caregiver may not be alerted remotely when assigned patient protocols are disabled, including bed exit, siderail position, brakes off, bed height changes, head of bed angle changes, and turn reminders. This failure to alert caregivers may prevent timely response to critical changes in patient safety settings.

The affected software versions were distributed nationwide to healthcare facilities in Oregon, South Carolina, Virginia, Tennessee, Georgia, North Carolina, Colorado, and Florida.

The recalled product

Product: Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Patient Monitoring Software
Hazard: alert-suppression
caregiver-notification-failure
Affected units: 8

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 (9)

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

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · alert suppression