NaviCare Patient Safety V3 — Class II medical device recall Z-2007-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-07-05, distributed nationwide. Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter
| Recall number | Z-2007-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-05-19 |
| Classified | 2023-06-26 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 7 software |
| UPC / GTIN / UDI-DI | 00887761985193 |
Product
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2007-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.