Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Reported: July 5, 2023 Initiated: May 19, 2023 #Z-2006-2023
Product Description
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 8 software versions
- Distribution
- US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed. Recalled by Baxter Healthcare Corporation. Units affected: 8 software versions.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2006-2023.
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