# FDA recall Z-2006-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-05-19.

## Product

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, 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.

## Distribution

US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.

## Key facts

- **Recall number:** Z-2006-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-19
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2006-2023

## Citation

> AI Analytics. FDA recall Z-2006-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2006-2023. Source: US FDA. Licensed CC0.

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