Xhibit Telemetry ReceiverRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10841522100246), received between Aug 8, 2024 and Sep 21, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (16 reports).

3 FDA recall records name this device's identifier, 3 still open.

3 other recalls cover devices cleared under the same FDA submission (K141156); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 25, 2024Open, Classified

   Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.

   Z-0810-2025 · Root cause: Software change control · FDA record ↗

2. Nov 25, 2024Open, Classified

   Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.

   Z-0809-2025 · Root cause: Labeling design · FDA record ↗

3. May 31, 2022Open, Classified

   Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

   Z-1513-2022 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026No Display/Image; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847374 ↗
• MalfunctionSep 4, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50623670 ↗
• MalfunctionJun 15, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS TECHNICAL SUPPORT TO REPORT THAT FIVE TELEMETRY CHANNELS WENT OFFLINE WHILE BEING MONITORED ON AN XHIBIT CENTRAL STATION (XCS). THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. THE BIOMED STATED THAT THEY RETUNED ALL THE AFFECTED CHANNELS TO RESTORE MONITORING. THE TECHNICAL SUPPORT REPRESENTATIVE PULLED XHIBIT TELEMETRY RECEIVER (XTR) LOGS. THE LOGS WERE EVALUATED BY A PRODUCT SUPPORT SPECIALIST (PSS). THE PSS FOUND THAT THE HAD BEEN ASSIGNED TO AN XTR THAT WAS NO OFFLINE. THE PSS ADVISED THE CUSTOMER BIOMED TO RESET THE XTR. AFTER THE XTR RESET, THE DEVICE WAS NOW COMMUNICATING ON THE NETWORK. THE PSS REVIEWED LOGS AND FOUND THAT THE XTR HAD CRASHED AFTER JUST OVER SIX MONTHS OF RUN TIME. THE PSS ADVISED THE CUSTOMER OF THE MAINTANCE SCHEDULE, STATING THE XTRS SHOULD BE RESTARTED AT LEAST ONCE EVERY 200 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512784 ↗
• MalfunctionJun 4, 2026Communication or Transmission Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT AFTER A BRIEF POWER OUTAGE TELEMETRY MONITORING DID NOT RETURN AS EXPECTED. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. TECHNICAL SUPPORT REMOTELY CONNECTED AND RESTARTED THE AFFECTED XHIBIT TELEMETRY RECIEVER (XTR) AND CONFIRMED THAT THE ISSUE WAS RESOLVED. CAUSE OF FAILURE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401841 ↗
• MalfunctionApr 30, 2026Communication or Transmission Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT THEY LOST SIXTEEN TELEMETRY PATIENTS ACROSS ALL CENTRAL STATIONS. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. A SPACELABS HEALTHCARE TECHNICAL SUPPORT REPRESENTATIVE REMOTELY CONNECTED AND VERIFIED THAT THE TELEMETRY CHANNELS WERE NO LONGER ONLINE. TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT ONE OF THE XHIBIT TELEMETRY RECEIVERS (XTR) APPEAR TO HAVE GONE OFFLINE. TO RESUME MONITORING, TECHNICAL SUPPORT RECOMMENDED THE CUSTOMER READMIT THE PATIENTS. THE CUSTOMER WAS ADVISED TO HAVE A BIOMED INSPECT THE XTR. SEVERAL FOLLOW UP ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, HOWEVER NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049237 ↗
• MalfunctionFeb 4, 2026Communication or Transmission Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT SEVERAL TELEMETRY PATIENTS WERE UNABLE TO BE MONITORED ON A XHIBIT CENTRAL STATION. NO PATIENT HARM WAS REPORTED. THE ISSUE RESOLVED WITHOUT INTERVENTION. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264934 ↗
• MalfunctionJan 15, 2026Application Program Freezes or Fails to Launch

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT THEIR XHIBIT TELEMETRY RECEIVER (XTR) RESTARTED AND WAS OFFLINE FOR ABOUT FIVE MINUTES BEFORE RETURNING ON ITS OWN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A SPACELABS PRODUCT SUPPORT SPECIALIST (PSS) REMOTELY CONNECTED AND GATHERED XTR LOGS. PER THE LOG REVIEW, THE XTR WENT THROUGH A SERVICE RESTART. FOLLOWING THE RESTART A QUAD RECEIVER CARD (QRC) FAILED TO INITIALIZE PROPERLY, CAUSING A DELAY IN THE WAVEFORMS TO RETURN TO THE CENTRAL STATION. CAUSE OF FAILURE COULD NOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090448 ↗
• MalfunctionDec 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT ALL TELEMETRY BEDS WENT OFFLINE AT THE XHIBIT CENTRAL STATION. SPACELABS HEALTHCARE TECHNICAL SUPPORT REMOTELY CONNECTED AND CONFIRMED THAT THE TELEMETRY RECEIVERS WERE NOT SENDING ANY DATA. THE ISSUE WAS ESCALATED TO THE CUSTOMER'S INTERNAL IT TEAM. IN A FOLLOW UP CALL WITH THE CUSTOMER, IT WAS CONFIRMED THAT IT WAS ABLE TO RESOLVE THE FAILURE BY RESTARTING THE XHIBIT TELEMETRY RECEIVER. WHILE CAUSE OF FAILURE COULD NOT BE ESTABLISHED, THE CUSTOMER CONFIRMED NO FURTHER ISSUES FOLLOWING THE RESTART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854470 ↗
• MalfunctionOct 12, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS AT TWO XHIBIT CENTRAL STATIONS (XCS), MULTIPLE TELEMETRY PATIENTS WENT OFFLINE. A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST (PSS) PERFORMED TROUBLESHOOTING AND A LOG REVIEW AND IDENTIFIED THAT THE XHIBIT TELEMETRY RECEIVER (XTR) FARM WAS EXCEEDING CONNECTIONS. THE PSS INFORMED THE CUSTOMER THAT THEY WOULD NEED TO EVALUATE THEIR CONNECTIONS TO REDUCE ANY FURTHER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23273769 ↗
• MalfunctionOct 12, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT SEVERAL TELEMETRY BEDS WENT OFFLINE FOR A BRIEF PERIOD OF TIME UNEXPECTANTLY. A PRODUCT SUPPORT SPECIALIST (PSS) GATHERED DEVICE LOGS AND WAS ABLE TO CONFIRM THE PATIENTS HAD GONE OFFLINE. THE LOGS INDICATED THAT THE XHIBIT TELEMETRY RECEIVER (XTR) HAD RESTARTED, BUT THERE WAS NOT ENOUGH INFORMATION IN THE LOGS TO INDICATE THAT THE RESTART WAS UNPROMPTED. THE PSS CONTACTED THE CUSTOMER TO CONFIRM IF THEY HAD RESTARTED THE RECEIVER DURING THE TIME THE PATIENTS WERE OFFLINE, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP MDR WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23273765 ↗
• MalfunctionSep 4, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT A XHIBIT TELEMETRY RECEIVER (XTR) HAD UNEXPECTEDLY RESTARTED RESULTING IN A LOSS OF TELEMETRY MONITORING. A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED XTR LOGS AND CONFIRMED THE CRASH, HOWEVER, CAUSE OF THE CRASH WAS NOT DETERMINED. THE PSS IS CURRENTLY WORKING WITH THE CUSTOMER TO GATHER ADDITIONAL DATA TO DETERMINE CAUSE OF FAILURE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974508 ↗
• MalfunctionAug 29, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS, SEVEN BEDS WENT OFFLINE UNEXPECTANTLY. A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST GATHERED THE EVENT DATA AND DEVICE LOGS TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE SEVEN PATIENTS WERE ADMITTED TO THREE DIFFERENT XHIBIT TELEMETRY RECEIVERS (XTR). A REVIEW OF THE DATA SHOWED THAT THE PATIENTS ADMITTED TO TWO OF THE THREE XTRS DID NOT LOSE MONITORING AT ANYTIME DURING THE EVENT. HOWEVER IT WAS FOUND THAT THE PATIENTS ADMITTED TO THE THIRD XTR DID LOSE MONITORING FOR APPROXIMATELY 30 SECONDS BEFORE RETURNING ON THEIR OWN. FURTHER REVIEW OF THE DATA SHOWED THAT THE XTR HAD RESTARTED UNEXPECTANTLY, WHICH RESULTED IN THE GAP IN MONITORING. AS A PRECAUTION, THE DEVICE WAS REMOVED FROM SERVICE AND THE CUSTOMER WILL RETURN IT TO SPACELABS HEALTHCARE FOR ADDITIONAL INVESTIGATION. AT THIS TIME, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929520 ↗
• MalfunctionAug 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT DURING A STORM, TELEMETRY PATIENTS STOPPED DISPLAYING WAVEFORM. INITIALLY, IT WAS REPORTED THAT TELEMETRY WAS SHOWING SQUELCH, HOWEVER WHEN TECH SUPPORT REMOTELY CONNECTED ALL EXHIBIT TELEMETRY RECEIVERS (XTR) WENT OFFLINE. A FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND ADVISED THE CUSTOMER RESTART ALL XTRS, WHICH DID NOT RESOLVE THE OUTAGE. THE TELEMETRY PATIENTS WERE THEN DISCHARGED AND READMITTED, WHICH ULTIMATELY RESOLVED THE ISSUE. CAUSE OF FAILURE WAS NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909687 ↗
• MalfunctionAug 1, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED FREQUENT TELEMETRY SYSTEM ISSUES WHERE PATIENT DATA WOULD STOP DISPLAYING ON A CENTRAL STATION UNTIL THE XHIBIT TELEMETRY RECEIVER (XTR) WAS RESTARTED. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER WENT ON SITE AND COULD NOT VERIFY THE REPORTED ISSUE AND COULD NOT FIND ANY FAULTS WITH ANY XTR. XTR LOGS WERE PULLED AND PROVIDED TO A PRODUCT SUPPORT SPECALIST (PSS). THE PSS REVIEWED THE LOGS AND FOUND THAT THE BIOS SETTINGS WERE INCORRECT ALL FIVE OF THE XTRS. THE FSE ATTEMPTED TO ADDRESS THE BIOS ISSUE VIA SOFTWARE RELOAD, HOWEVER THE FIRST XTR WOULD NOT LOAD THE SOFTWARE. THE FSE STATED THAT HE WOULD ORDER PARTS TO REPLACE HARDWARE. A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692960 ↗
• MalfunctionAug 1, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS, TWO BEDS WENT OFFLINE. THE USER MOVED THE PATIENTS TO NEW TRANSMITTERS AND THE BIOMED REPORTED THAT THE ISSUE WAS RESOLVED. THE CUSTOMER CALLED BACK ON 3/JULY STATING THE ISSUE REAPPEARED WITH TWO DIFFERENT TRANSMITTERS. THE PATIENTS WERE ONCE AGAIN MOVED TO NEW TRANSMITTERS TO RESOLVE THE FAILURE. THE BIOMED STATED THAT HE HAD TESTED THE TRANSMITTERS AND COULD NOT FIND ANY ISSUES. SPACELABS HEALTHCARE REMOTELY CONNECTED AND FOUND FOUR RECEIVER SLOTS WERE DISABLED ON A EXHIBIT TELEMETRY RECEIVER (XTR) QUAD RECEIVER CARD (QRC). A FIELD SERVICE ENGINEER (FSE) WAS PAGED TO GO ON SITE, NO BEDS WERE FOUND OFFLINE. ALL XTRS WERE RESTARTED WHILE THE FSE WAS ON SITE AS PART OF PREVENTIVE MAINTENANCE. CAUSE OF FAILURE WAS NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692957 ↗
• MalfunctionJul 11, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT AFTER A NETWORK DROP AT THE FACILITY, FOUR PATIENTS HAD NOT RESUMED MONITORING ON THEIR OWN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. A SPACELABS HEALTHCARE TECHNICAL SUPPORT REPRESENTATIVE CONFIRMED THAT ALL FOUR PATIENTS WERE ON ONE XHIBIT TELEMETRY RECEIVER (XTR). IT WAS CONFIRMED THAT THE XTR WAS RECEIVING THE TELEMETRY DATA, HOWEVER, IT APPEARED THE DATA WAS NOT BEING TRANSMITTED TO THE XHIBIT CENTRAL STATION OR ICS. THE TECHNICAL SUPPORT REPRESENTATIVE MOVED ALL AFFECTED CHANNELS TO ANOTHER SYSTEM AND RESTARTED THE XTR TO RESTORE NETWORK COMMUNICATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487798 ↗
• MalfunctionJul 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED A FEW TELEMETRY BOXES WOULD DROP OFF THE XHIBIT CENTRAL STATIONS (XCS) INTERMITTENTLY. THE TELEMETRY PATIENTS WOULD RETURN ON THEIR OWN, HOWEVER CUSTOMER SETTINGS AND NOTES WERE SET TO DEFAULT. A FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THE SYSTEM WAS OPERATIONAL. AN ERROR MESSAGE WAS SEEN IN THE XCS MESSAGE BAR INDICATES THE XHIBIT TELEMETRY RECEIVER (XTR) HAD DISCONNECTED AND RECONNECTED. AS A PRECAUTION THE FSE GATHERED DEVICE LOGS AND FORWARDED THEM TO THE PRODUCT SUPPORT SPECIALIST (PSS) FOR ADDITIONAL INVESTIGATION. APSS REVIEWED THE XCS LOGS AND CONFIRMED THAT A XTR HAD DISCONNECTED ON 9/JUN/2025 FOR ROUGHLY 30 SECONDS. XTR LOGS WERE UNAVAILABLE FOR REVIEW. A PSS MADE SEVERAL ATTEMPTS TO REACH OUT TO THE CUSTOMER TO GATHER ADDITIONAL DATA REGARDING THE LOSS OF TELEMETRY MONITORING AND ACCESS TO THE XTR LOGS, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. SHOULD ADDITIONAL INFORMATION BE MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476005 ↗
• MalfunctionJun 30, 2025Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT THEY HAD A FAILURE TO ALARM FOR A VENTRICULAR TACHYCARDIA. DUE TO THE DELAY IN THE CUSTOMER REPORTING THE EVENT TO SPACELABS HEALTHCARE, WAVEFORM DATA WAS NO LONGER ABLE TO BE REVIEWED AS THE DATA HAD BEEN PURGED. ADDITIONALLY, IT WAS UNCLEAR WHICH XHIBIT TELEMETRY RECEIVER (XTR) WAS INVOLVED WITH THE EVENT. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE ALL THE XTRS AT THE CUSTOMERS SITE THAT COULD HAVE BEEN ASSOCIATED WITH THE EVENT. ALL OF THE XTRS PASSED FUNCTIONAL AND PERFORMANCE TESTING. THE FSE GATHERED XTR LOGS AND FORWARDED TO A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST FOR ADDITIONAL REVIEW. WHEN THE REVIEW OF DATA IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352731 ↗
• MalfunctionJun 20, 2025Complete Loss of Power; Complete Loss of Power

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS ON A XHIBIT CENTRAL STATION (XCS), ALL PATIENTS WENT OFFLINE. SPACELABS HEALTHCARE TECHNICAL SUPPORT WALKED THE USER THROUGH RESTARTING THE XCS AND THE CUSTOMER STATED THAT BEDSIDE PATIENTS RETURNED, HOWEVER, TELEMETRY PATIENTS CONTINUED TO SHOW OFFLINE. THE CUSTOMER LATER IDENTIFIED THAT THE XHIBIT TELEMETRY RECEIVER (XTR) WAS FOUND TO BE OFF. ONCE THE DEVICE WAS POWERED BACK ON, THE MISSING TELEMETRY PATIENTS REAPPEARED AT THE XCS. LOGS WERE COLLECTED FROM TWO DIFFERENT XTRS. AT THIS TIME, THE LOGS HAVE NOT BEEN REVIEWED TO DETERMINE CAUSE OF FAILURE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294659 ↗
• MalfunctionMay 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THEY EXPERIENCED POWER DISRUPTION AT THEIR FACILITY. WHEN THE POWER WAS RESTORED, MOST PATIENT MONITORING RESUMED, HOWEVER 18 TELEMETRY PATIENTS WERE SHOWING OFFLINE. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER WORKED WITH THE CUSTOMER TO PERFORM TROUBLESHOOTING OF THE XHIBIT TELEMETRY RECEIVERS (XTR). TWO DIFFERENT FAULTY XTRS WERE IDENTIFIED, ALL PATIENTS ASSOCIATED WITH THE TWO XTRS WERE SHOWING OFFLINE AT THE CENTRAL STATION WHILE SHOWING WAVEFORMS AT THE RECEIVER. THE PATIENTS WERE TRANSFERRED TO DIFFERENT XTRS AND THE FAULTY XTRS WERE RESTARTED. FOLLOWING THE RESTART, IT WAS CONFIRMED THE NETWORK COMMUNICATION WAS RESTORED, CHANNELS WERE ABLE TO BE TUNED AND MONITORED AND NO FURTHER ISSUES WERE OBSERVED. THE LOGS FROM THE XTRS AND PROVIDED TO A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST (PSS). THE PSS IDENTIFIED THAT THE TWO FAULTY XTRS LOST NETWORK COMMUNICATION RELATING TO THE POWER DISRUPTION AND RESTARTED, HOWEVER UPON RESTART, THE XTRS FAILED TO ESTABLISH CONNECTIONS DUE TO A FAILURE TO PROPERLY RESTART. ONCE THE XTRS WERE RESTARTED AGAIN, THE ERRORS PREVENTING THE COMMUNICATION WERE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117188 ↗
• MalfunctionApr 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS, SIX PATIENTS DROPPED OFF THE CENTRAL FOR A BRIEF PERIOD OF TIME BEFORE RETURNING ON ITS OWN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770407 ↗
• MalfunctionJan 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT MID-MONITORING SEVERAL TELEMETRY PATIENTS WENT OFFLINE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284192 ↗
• MalfunctionJan 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS ON A EXHIBIT CENTRAL STATION, THE CENTRAL LOST ALL TELEMETRY CHANNELS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230822 ↗
• MalfunctionJan 10, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS THEY LOST NETWORK CONNECTIVITY TO THE XHIBIT TELEMETRY RECEIVER, RESUTING A LOSS OF MONITORING. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126969 ↗
• MalfunctionJan 10, 2025Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS, ALARM MESSAGES FAILED TO ESCALATE TO HIGHER PRIORITY LEVELS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141156. One submission often covers many models, so check the product and lot details in each record.

• Z-0532-2018 · Jan 17, 2018 · Terminated
  Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Tel
• Z-2886-2016 · Aug 25, 2016 · Terminated
  Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital
• Z-1502-2016 · Mar 28, 2016 · Terminated
  The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.