Voalte Nurse Call 4.0Recalls & reported problems
Hill-Rom, Inc. · Hospital Paging System · Class 2
All models of Voalte Nurse Call (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Voalte Nurse Call 4.0 is a hospital paging system. Its 409 adverse event reports often describe calls and alarms that did not announce or show up, such as code blue calls and bed exit alerts. The reports include 2 deaths and 10 injuries. Two recalls are closed, over a firmware memory leak in a supplier component and a component that can fail to finish rebooting.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 405
- Deaths reported
- 2
- Injuries reported
- 10
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 405 adverse event reports that list this exact device (DI 00887761995079), received between Aug 8, 2022 and Sep 24, 2026 — classified as 2 deaths, 10 injuries, 393 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (394 reports).
2 FDA recall records name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Apr 13, 2022Class IITerminated
Firm discovered a firmware memory leak with a supplier-manufactured component.
Z-1094-2022 · Root cause: Software design · Recall details · FDA record ↗
- Oct 14, 2021Class IITerminated
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
Z-0402-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Alarm System394
- Defective Alarm4
- Alarm Not Visible2
- No Audible Alarm2
- Activation Problem1
- Audible Prompt/Feedback Problem1
- Failure to Sense1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions390
- Fall3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bone Fracture(s)2
- Head Injury2
- Laceration(s)2
- Abrasion1
- Hematoma1
Recent adverse event reports
The 25 most recent of 405 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Device Alarm System
Baxter received a report stating the NURSE CALL INSTALLATION code blue got the wrong location in the screen when they activated it. This occurred during patient use. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888539 ↗MalfunctionSep 3, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50598457 ↗MalfunctionAug 16, 2026Device Alarm System
Baxter received a report stating the NURSE CALL INSTALLATION bed exit alert is not showing in the dome light and the grs10. This occurred during patient use. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266214 ↗MalfunctionAug 13, 2026Device Alarm System
Baxter received a report stating the NURSE CALL INSTALLATION code blue was not showing in pbx grs10. This occurred during patient use. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231773 ↗MalfunctionAug 12, 2026Device Alarm System
Baxter received a report stating the NURSE CALL INSTALLATION bed exit alarm was not annunciating. The process step during which this occurred was unknown. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230149 ↗MalfunctionAug 11, 2026Device Alarm System
Baxter received a report stating the NURSE CALL SERVER bed exit alert did not announce. This occurred during patient use. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203834 ↗MalfunctionAug 7, 2026Device Alarm System
Baxter received a report stating the NURSE CALL INSTALLATION Bed exit alarms were not alerting to nurse station intermittently. The process step during which this occurred was unknown. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183169 ↗MalfunctionJul 3, 2026Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE NURSE CALL INSTALLATION CODE CALL DID NOT ALERT TO SECONDARY LOCATION. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709042 ↗MalfunctionJul 3, 2026Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE NURSE CALL INSTALLATION BED EXIT CALL WAS ALERTING AS A REGULAR CALL. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707697 ↗MalfunctionJul 3, 2026Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE NURSE CALL INSTALLATION GRS5 WOULD NOT RESPOND WHEN PULLED. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707102 ↗MalfunctionJul 2, 2026Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE NURSE CALL INSTALLATION DURESS CALL DID NOT ANNUNCIATE.THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25691762 ↗MalfunctionJun 26, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION BED EXIT ALERT WAS NOT TRIGGERING INSIDE THE ROOM. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. IT WAS UNKNOWN IF ANY SECOND DEVICE WAS ALSO INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25632614 ↗MalfunctionJun 26, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION CODE BLUE CALLS WERE NOT ALERTING AT HALLWAY.THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25632573 ↗MalfunctionJun 23, 2026Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE NURSE CALL INSTALLATION HAD THE CODE BLUE CALL NOT ANNUNCIATING. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598223 ↗MalfunctionJun 23, 2026Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE NURSE CALL INSTALLATION CODE CALL ANNUNCIATING AS A DIFFERENT TYPE OF CALL. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597423 ↗MalfunctionJun 19, 2026Device Alarm System
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION CODE STROKE DID NOT ALERT. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY. THE DEVICE WAS NOT REQUESTED FOR SERVICE AT THIS TIME SINCE TROUBLESHOOTING/INSPECTION WILL BE PERFORMED REMOTELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25558974 ↗MalfunctionJun 18, 2026Device Alarm System
BAXTER RECEIVED A REPORT STATING THAT NURSE CALL INSTALLATION BED DISCONNECT CALLS WERE NOT ANNOUNCING.THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551179 ↗MalfunctionJun 18, 2026Device Alarm System
BAXTER RECEIVED A REPORT STATING THAT NURSE CALL INSTALLATION BED EXIT ALARM WAS ALERTING AS EQUIPMENT ALARM. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25550033 ↗MalfunctionJun 18, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION VOLUME OF SYSTEM ON THE UNIT IS TOO LOW. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25542760 ↗MalfunctionJun 17, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION CODE BLUE POOR AND CONFUSING DESCRIPTION ON GRS10. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536621 ↗MalfunctionJun 16, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION EMERGENCY STAFF CALL WAS NOT ROUTED CORRECTLY. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25515211 ↗MalfunctionJun 16, 2026Device Alarm System
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION GRS10 WAS NOT SHOWING THE PATIENT ROOM WITH A CODE CALL. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY. THE DEVICE WAS NOT REQUESTED FOR SERVICE AT THIS TIME SINCE TROUBLESHOOTING/INSPECTION WILL BE PERFORMED REMOTELY. THERE WERE NO SYSTEM ALERTS OR OTHER VISUAL/ AUDIBLE ERROR INDICATORS WERE PRESENT PRIOR TO THE EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25515113 ↗MalfunctionJun 16, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL SERVERCODE CALLS WERE NOT ALERTING AT PRIMARY CONSOLE. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25515068 ↗MalfunctionJun 5, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION THE FALL RISK ALERT LIGHTS WERE NOT FLASHING. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. IT WAS UNKNOWN IF ANY SECOND DEVICE WAS ALSO INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25404316 ↗MalfunctionMay 28, 2026Device Alarm System
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT NURSE CALL INSTALLATION CODE BLUE NOT MAKING ALERT SOUND. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. IT WAS UNKNOWN IF ANY SECOND DEVICE WAS ALSO INVOLVED. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313167 ↗
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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 · each report above links to its original FDA record
- 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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