Baxter recalls Voalte Patient Safety software versions 4.0.000-4.0.401 used with Centrella beds due to potential alert suppression. Affected units may not alert caregivers to patient safety changes.
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.
Baxter is recalling Voalte Patient Safety software versions 4.0.000 to 4.0.401 that are used with Centrella beds. These versions may suppress safety alerts, meaning caregivers won't be notified if patient positions or bed settings change.
The software may enter a state where safety alerts for patient movements and bed positions stop working. This means caregivers won't get warnings if a patient's bed position changes or if they move out of a safe position.
Healthcare facilities using the Voalte Patient Safety software with Centrella beds are affected. Caregivers and patients at facilities using these specific software versions are most at risk.
Check if your Voalte Patient Safety software version is 4.0.000 to 4.0.401. The product uses Centrella beds and has UDI/DI number 00887761995086.
Verify your Voalte Patient Safety software version is 4.0.000 to 4.0.401 using the UDI/DI number 00887761995086.
Baxter identified a potential risk where the safety monitoring features may enter a permanent state of alert suppression, meaning caregivers won't be notified if patient positions or bed settings change.
Check your software version. If it's 4.0.000 to 4.0.401, contact Baxter for guidance on next steps.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2006-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2006-2023 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
