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.
What this means for you
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
- Hazard
- alert-suppression
- monitoring-failure
- patient-safety-risk
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.
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