Voalte Patient Safety 4.0Recalls & reported problems
Hill-Rom, Inc. · Medical Software · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- May 19, 2023Class IIOpen, Classified
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.
Z-2006-2023 · Root cause: Device Design · Recall details · FDA record ↗
Other MONITOR, BED PATIENT devices
- POSEY 8645Posey Products, LLC · Monitor, Bed Patient1 death60 reports
- NaviCare® Patient Safety Systems 3.9Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- Cubby Beds KIT10001Sensory Medical, Inc. · Monitor, Bed Patient30 reports
- Medline MDT8450YMedline Industries, Inc. · MONITOR, BED PATIENT29 reports
- POSEY 8309ELPosey Products, LLC · Monitor, Bed Patient2 deaths19 reports
- POSEY 8399Posey Products, LLC · Monitor, Bed Patient19 reports
- POSEY 8645WLPosey Products, LLC · Monitor, Bed Patient17 reports
- POSEY 8345Posey Products, LLC · Monitor, Bed Patient1 death12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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