NaviCare® Nurse Call Systems 3.9Recalls & reported problems
Hill-Rom, Inc. · Hospital Paging System · Class 2
All models of NaviCare Nurse Call Systems (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Hill-Rom NaviCare nurse call system has 87 reports in the FDA database, including 2 deaths and 3 injuries. Many reports describe alarms that did not sound, and one describes a patient falling when a nurse call did not alarm. Reports fell to 0 in the past 12 months from 9 the year before. It has 2 closed recalls from 2021 and 2022, over a firmware memory leak and a component that could fail to reboot.
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
- 87
- Deaths reported
- 2
- Injuries reported
- 3
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00887761985209), received between Jan 15, 2020 and Jun 30, 2025 — classified as 2 deaths, 3 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (72 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-1093-2022 · 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 System72
- No Audible Alarm11
- Defective Alarm2
- Computer Software Problem1
- Delayed Alarm1
- False Alarm1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- Fall4
- Cardiac Arrest1
- Death1
- Hemorrhagic Stroke1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED EXIT OFF ALERT DID NOT ANNUNCIATE. . THERE WAS NO PATIENT/USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367487 ↗InjuryJun 13, 2025Defective Alarm; Defective Alarm
IT WAS REPORTED A VOALTE NURSE CALL DID NOT ALARM AND A PATIENT FELL. THE PATIENT WAS FOUND ON THE FLOOR DUE TO AN UNWITNESSED FALL. THE PATIENT SUSTAINED AN ¿ACUTE HEMORRHAGE TO THE LEFT FRONTAL LOBE.¿ THE CUSTOMER REPORTED THAT THE PATIENT¿S INJURY ¿REMAINED STABLE,¿ ¿NO ACUTE NEUROSURGICAL INTERVENTION WAS INDICATED OR REQUIRED,¿ AND THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. THE BED¿S EXIT ALARM WAS ACTIVATED AND SIGNALING; HOWEVER, THE VOALTE NURSE CALL DID NOT TRIGGER. A REVIEW OF THE NURSE CALL LOGS SHOWS THAT THE ASSOCIATED BED WAS OFFLINE (NOT CONNECTED VIA COMMUNICATION CABLE) PRIOR TO AND LEADING UP TO THE REPORTED EVENT, INDICATING THAT THE COMMUNICATION CABLE THAT CONNECTS THE BED TO THE NURSE CALL SYSTEM WAS NOT CONNECTED AT THE TIME OF THE EVENT. ADDITIONALLY, THE LOG FILE SHOWED THAT OTHER FEATURES OF THE NURSE CALL SYSTEM (STAFF LOCATING) FUNCTIONED AS DESIGNED. FURTHERMORE, AN INSPECTION OF THE ASSOCIATED BED PERFORMED BY THE FACILITY NOTED THE BED TO BE WORKING AS INTENDED. THE CAUSE OF THE EVENT CAN BE ATTRIBUTED TO USE ERROR (FAILURE OF THE CAREGIVER TO CONNECT THE BED TO THE NURSE CALL SYSTEM AND NOT DUE TO A MALFUNCTION OF THE NURSE CALL SYSTEM
Patient problems: Fall; Hemorrhagic Stroke
MAUDE report 22202384 ↗MalfunctionJun 6, 2025Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE CALLS WERE NOT ANNUNCIATING AT THE SECONDARY SITE. THERE WAS NO PATIENT/USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22161234 ↗MalfunctionMay 20, 2025Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED DISCONNECT ALERT WAS NOT ALARMING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053204 ↗MalfunctionApr 2, 2025Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED EXIT WAS ANNUNCIATING AS A NORMAL CALL. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21759177 ↗MalfunctionMar 24, 2025Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED EXIT CALL WAS SHOWING AS A NORMAL CALL. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677036 ↗MalfunctionFeb 7, 2025Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE BLUE DID NOT ANNUNCIATE AT THE PBX. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21339750 ↗MalfunctionNov 25, 2024Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THAT THE BED EXIT ALARM DOES NOT SHOW ON THE NURSE CONSOLE AND ALSO THE DOME LIGHT OUTSIDE ROOM DOES NOT LIGHT UP YELLOW. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770280 ↗MalfunctionNov 19, 2024Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THAT THEY PUSHED STAFF ASSIST AND PULLED CODE BLUE LEVER AND PBX NEVER GOT AN ALERT. THERE WAS NO PATIENT IMPACT OR SAFETY ISSUES REPORTED AS A RESULT OF PRODUCT PERFORMANCE. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20721948 ↗MalfunctionOct 18, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE DURESS CALL WAS NOT ANNUNCIATING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20488841 ↗MalfunctionOct 9, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE BLUE WAS NOT ANNUNCIATING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410862 ↗MalfunctionSep 30, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE CALL WAS NOT ANNUNCIATING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340659 ↗MalfunctionSep 17, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE CALL WAS NOT ANNUNCIATING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237987 ↗MalfunctionAug 13, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CALLS WERE NOT GOING TO ICU & ED CONSOLES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19975691 ↗MalfunctionAug 9, 2024Device Alarm System; Device Alarm System
HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE CALLS WERE NOT ANNUNCIATING IN THE PBX. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19956524 ↗MalfunctionJul 18, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE BLUE PULL SWITCH WAS NOT WORKING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19779135 ↗MalfunctionJul 15, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED ALARM WAS RINGING AS A NORMAL CALL. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746775 ↗MalfunctionJul 12, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE CALLS WERE NOT ALERTING AT THE SECONDARY LOCATION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19729549 ↗MalfunctionJun 26, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE ALERTS HAD NO VOLUME. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19619528 ↗MalfunctionJun 26, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE CODE CALLS WERE NOT ALERTING IN THE PBX. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19616582 ↗MalfunctionJun 18, 2024Defective Alarm; Defective Alarm
HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE DID NOT ANNUNCIATE IN THE SECONDARY LOCATION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563408 ↗MalfunctionJun 14, 2024Device Alarm System; Device Alarm System
HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE HAD THE INCORRECT TONE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538184 ↗MalfunctionMay 16, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE BED EXIT WASN'T ALERTING IN ROOM OR NURSE STATION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337629 ↗MalfunctionMay 15, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE ASBC WAS NOT GETTING THE BED EXIT CALL. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19321675 ↗MalfunctionMay 2, 2024Device Alarm System; Device Alarm System
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THAT GRS5 DID NOT ANNUNCIATE CODE CALL. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19235626 ↗
Other System, communication, powered devices
- Voalte Nurse Call 4.0Hill-Rom, Inc. · System, communication, powered2 recalls2 deaths405 reports
- NaviCare® Nurse Call Systems 3.6Hill-Rom, Inc. · System, communication, powered1 recall12 reports
- NaviCare® Nurse Call Systems 3.7Hill-Rom, Inc. · System, communication, powered1 recall0 reports
- Tobii Dynavox TD I-110Tobii Dynavox LLC · System, Communication, Powered1 recall0 reports
- Voalte Nurse Call 4.1Hill-Rom, Inc. · System, communication, powered14 reports
- GEN4 DIRECT ACCESS 4C370U-P10424CCurbell Medical Products, Inc. · System, Communication, Powered3 reports
- GEN4 PLUS, RESPONDER 5, ENHANCED 5C410U-10134003ACurbell Medical Products, Inc. · System, Communication, Powered3 reports
- HomeSafe AutoAlert Pendant 300000219851Lifeline Systems Company · System, communication, powered2 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 · 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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