Agency classClass IIOur severity:High FDA (Devices)·Z-2007-2023·Announced 2023-07-05

NaviCare Patient Safety software versions recalled for alert suppression defect

Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.

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: FDA Class II medical device recall where a software malfunction prevents safety monitoring and caregiver alerts for critical patient events. No injuries have been reported, but the loss of monitoring capabilities for bed exits, positioning, and brakes creates significant risk to patient safety.

Plain-English summary

Baxter Healthcare Corporation is recalling seven versions of NaviCare Patient Safety software (versions 3.9.200, 3.9.201, 3.9.300, 3.9.400, 3.9.401, 3.9.500, and 3.9.600) used with Centrella hospital beds. The affected software was distributed nationwide to healthcare facilities in Oregon, South Carolina, Virginia, Tennessee, Georgia, North Carolina, Colorado, and Florida.

A software defect may cause safety monitoring and bed exit monitoring features to enter a permanent state of alert suppression. When this occurs, caregivers may not receive remote notifications when assigned patient safety protocols are disabled or changed. Affected monitoring includes bed exit detection, siderail position monitoring, brake status, bed height adjustments, head of bed positioning, and turn reminders.

Healthcare facilities using Baxter Centrella beds should verify their installed software version. Facilities with any of the seven affected software versions should contact Baxter Healthcare Corporation for instructions on obtaining and installing updated software that restores monitoring and caregiver alerting capabilities.

The recalled product

Product: NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Patient Monitoring Software
Hazard: alert-suppression
monitoring-failure
patient-safety-risk
Affected units: 7

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 (8)

UDI/DI 00887761985193
Software Versions: 3.9: 3.9.200
3.9.201
3.9.300
3.9.400
3.9.401
3.9.500
3.9.600

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