Recall archive / FDA device enforcement
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed — FDA record Z-2007-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 7 software versions
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2007-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 5, 2023
- Recall initiation date
- May 19, 2023
- Center classification date
- Jun 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.