Severity
Moderate
FDA Devices recall · Reported July 5, 2023
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…
Baxter Healthcare Corporation recalled NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed - a moderate-severity action.
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed was recalled by Baxter Healthcare Corporation in July 5, 2023. Reason: Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter…. Check the official notice for the remedy. Verify recall #Z-2007-2023 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this moderate-severity FDA Devices recall-Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2007-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2007-2023) was formally reported on July 5, 2023, with the manufacturer initiating the action on May 19, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 7 software versions.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
7 software versions
Related Recalls
6
3 from same agency
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2007-2023 |
| Date reported | July 5, 2023 |
| Date initiated | May 19, 2023 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 7 software versions |
| Distribution | US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 5, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.