RecallRadar

FDA Device recall Z-2007-2023

NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

On 2023-07-05 the FDA classified a Class II recall of NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed by Baxter Healthcare, citing 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 ma….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2007-2023
ClassificationClass II
Statusongoing
Initiated2023-05-19
Published2023-07-05
Last updated2026-09-13 11:56 UTC
CompanyBaxter Healthcare
DistributionUS

Product

NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

Reason

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.

Identifiers

code_infoUDI/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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2007-2023%22

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