Z-2007-2023Class II

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

Name: Z-2007-2023 NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Creator: Baxter Healthcare Corporation
Published: 2023-05-19
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-05-19 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed on 2023-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2007-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-19
Posted: 2023-06-26
Recalling firm: Baxter Healthcare Corporation
Product: NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/19/2023 by letter (USPS). The notice explained the issue, hazard, and requested the following: Baxter is asking that you take the following actions: 1. Share this letter with your IT department (or other relevant personnel) to determine if you have the impacted software version and contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week, to schedule a software upgrade which addresses the identified issue. 2. You may continue to use your Voalte Patient Safety Software (VPS) (with your Centrella bed) until a software upgrade is completed by implementing either of these options into your clinical bedside workflow: Option 1: When working with a patient in the room, and a bed exit alarm is activated, only silence the bed, and extend the silence timer instead of turning off bed exit. " At the Graphical Room Station (GRS), click Menu " Click Manage Bed " On the Manage Bed screen, click the Safety Alerts ON / OFF slider button and the Delay button will pop up. Extend the silence period for the desired amount of time. Option 2: After working with a patient in the room, and prior to exiting the room, enable Patient Safety at the Graphical Room Station (GRS). " At the Graphical Room Station, click Menu " Click Manage Bed on the Manage Bed screen, toggle the Safety Alerts button to ON . For general questions regarding this communication, contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week.
Quantity in commerce: 7 software versions
Distribution: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2007-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2006-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-26
Z-2007-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-26

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)