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Xhibit 96102Recalls & reported problems

Spacelabs Healthcare (Washington), Inc · XHIBIT CENTRAL STATION,96102 · Class 2

Quick summary

This Spacelabs Xhibit central station is the bedside monitoring unit that collects and displays telemetry patients' heart rhythms and alarms in a hospital. The 49 reports mostly describe the station shutting down on its own, freezing or failing to start, going blank, or dropping data and alarms, which left staff without monitoring until a reboot. There is 1 death, no injuries, and 48 malfunctions. One recall, started in August 2019 and closed, involved audio alarms being lost after a power failure or cable disconnection.

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
50
Deaths reported
1
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10841522100345), received between Apr 19, 2023 and Sep 24, 2026 — classified as 1 death, 49 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (19 reports).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K122146); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 5 reportsFeb 2025: 1 reportsMar 2025: 3 reportsApr 2025: 3 reportsMay 2025: 3 reportsJun 2025: 1 reportsJul 2025: 3 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 3 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 3 reportsApr 2026: 4 reportsMay 2026: 1 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 30, 2019Terminated

    The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

    Z-2261-2020 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Device problems

  • Unexpected Shutdown19
  • Application Program Freezes or Fails to Launch13
  • No Display/Image9
  • Communication or Transmission Problem4
  • Device Alarm System2
  • No Audible Alarm2
  • Application Program Problem1
  • Computer Software Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions49
  • Asystole1

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026No Audible Alarm

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50890510 ↗
  • MalfunctionJun 26, 2026Device Alarm System

    THE CUSTOMER REPORTED THAT AN XHIBIT CENTRAL STATION (XCS) FAILED TO ALARM FOR A 4.4 SECOND PAUSE. THERE WAS NO REPORT OF PATIENT HARM OR USER HARM ASSOCIATED WITH THIS EVENT. A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST IS CURRENTLY WORKING WITH THE CUSTOMER TO GET A FIELD SERVICE ENGINEER (FSE) ON SITE AND TO GATHER DATA ON THE EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. 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 25642745 ↗
  • MalfunctionJun 4, 2026No Display/Image

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT WHILE MONITORING TELEMETRY PATIENTS BOTH DISPLAYS OF THE XHIBIT CENTRAL STATION WENT BLANK. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. A SPACELABS TECHNICAL SUPPORT REPRESENTATIVE WALKED THE USER THROUGH PERFORMING A HARD REBOOT OF THE XCS. FOLLOWING THE REBOOT, THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. CAUSE OF FAILURE WAS NOT DETERMINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25401839 ↗
  • MalfunctionMay 7, 2026Unexpected Shutdown; Application Program Freezes or Fails to Launch

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT WHILE MONITORING TELEMETRY PATIENTS THE XHIBIT CENTRAL STATION (XCS) BECAME UNRESPONSIVE AND THEY LOST TELEMETRY MONITORING. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. A SPACELABS TECHNICAL SUPPORT REPRESENTATIVE WALKED THE USER THROUGH PERFORMING A HARD REBOOT OF THE XCS. FOLLOWING THE REBOOT, THE CUSTOMER CONFIRMED THEY WERE ABLE TO CONTINUE MONITORING. HOWEVER, THE CUSTOMER CALLED BACK SHORTLY AFTER STATING THE DEVICE WAS ACTING ERRATICALLY AGAIN. TECHNICAL SUPPORT ADVISED THE CUSTOMER REACH OUT TO THEIR BIOMED TO REPLACE THE XCS. LATER IN THE MORNING, THE BIOMED CALLED SPACELABS HEALTHCARE CUSTOMER SERVICE TO REQUEST REPAIR OF THE XCS REPORTING THAT THE DEVICE WAS OVERHEATING AND RANDOMLY POWERING DOWN. THE CUSTOMER SHIPPED THE DEVICE TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. THE DEVICE WAS EVALUATED BY AN EQUIPMENT SERVICE CENTER TECHNICIAN. THE TECHNICIAN REPORTED THAT THE UNIT WOULD POWER ON, THEN SHUT DOWN. THE UNIT WAS FOUND TO HAVE A FAULTY POWER SUPPLY AND VIDEO CARD AS WELL AS A DAMAGED FAN ON THE MOTHERBOARD. THE TECHNICIAN ALSO NOTED THAT THE DEVICE HAD A LOT OF DUST BUILT UP IN THE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25116428 ↗
  • MalfunctionApr 30, 2026Unexpected Shutdown

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REQUEST A DEPOT REPAIR FOR A XHIBIT CENTRAL STATION (XCS) THAT WOULD SHUT DOWN ON ITS OWN AFTER 3-5 MINUTES OF OPERATION. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RECEIVED BY SPACELABS HEALTHCARE AND THE REPORTED PROBLEM WAS VERIFIED DUE TO A FAULTY FAN ON THE VIDEO CARD. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XHIBIT CENTRAL STATION WAS NO LONGER REPAIRABLE, AND THAT THEY WOULD NEED TO REPLACE THE DEVICE. THE CUSTOMER CONFIRMED THEY WOULD OPT FOR THE REPLACEMENT UNIT IN LIEU OF REPAIR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25049235 ↗
  • MalfunctionApr 23, 2026Application Program Freezes or Fails to Launch

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT WHILE MONITORING TELEMETRY PATIENTS ON A XHIBIT CENTRAL STATION (XCS) THE CENTRAL HAD BECOME FROZEN AND UNRESPONSIVE. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. A SPACELABS TECHNICAL SUPPORT REPRESENTATIVE WALKED THE USER THROUGH PERFORMING A HARD REBOOT OF THE XHIBIT CENTRAL STATION. FOLLOWING THE REBOOT, THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. CAUSE OF FAILURE WAS NOT DETERMINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24975099 ↗
  • MalfunctionApr 17, 2026Unexpected Shutdown

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEIR XHIBIT CENTRAL STATION (XCS) WOULD RANDOMLY SHUT ITSELF OFF WHILE MONITORING TELEMETRY PATIENTS. NO PATIENT OR USER HARM WAS REPORTED IN ASSOCIATION WITH THE EVENT. A LOANER UNIT WAS SENT TO THE CUSTOMER AND THE FAULTY UNIT WAS SHIPPED TO SPACELABS FOR EVALUATION. AT THIS TIME, THE DEVICE HAS BEEN RECEIVED, HOWEVER, EVALUATION AND REPAIR HAS NOT YET BEEN COMPLETED. 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 24918495 ↗
  • DeathApr 10, 2026Device Alarm System

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT A PATIENT EXPIRED AFTER LEADS WERE REMOVED AND CLINICAL STAFF WERE UNAWARE. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND PULLED XHIBIT CENTRAL STATION (XCS) LOGS FROM THREE DIFFERENT XCS THAT WERE MONITORING THE PATIENT. THE LOGS WERE PROVIDED TO A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST (PSS). THE PSS REVIEWED THE LOGS AND CONFIRMED THAT THE XCSS ALARMED FOR BOTH ASYSTOLE AND LEADS OFF. THE LEADS OFF ALARMS WERE FOUND TO HAVE ESCALATED FROM MEDIUM TO HIGH PRIORITY AS EXPECTED. AT THIS TIME NO DEVICE MALFUNCTION WAS OBSERVED WITH THE XCS STATION AND IT WAS DETERMINED THAT THE SYSTEM ALARMED APPROPRIATELY.

    Patient problems: Asystole

    MAUDE report 24841570 ↗
  • MalfunctionMar 7, 2026No Display/Image

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT TWO OF THEIR THREE XHIBIT SCREENS ARE NOT DISPLAYING PATIENTS. A SOFTWARE RESTART WAS PERFORMED, PATIENTS WERE MANUALLY ADDED TO THE SECOND SCREEN, AND THE DISPLAY CABLE WAS RESEATED TO RESOLVE THE ISSUE. NO PATIENT OR USER HARM WAS REPORTED. THE CAUSE OF THE ISSUE IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24540675 ↗
  • MalfunctionMar 2, 2026Unexpected Shutdown

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEIR XHIBIT CENTRAL STATION UNEXPECTEDLY SHUT DOWN. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION AND THE REPORTED ISSUE WAS VERIFIED. THE CAUSE OF THE ISSUE WAS IDENTIFIED AS AN INOPERABLE VIDEO CARD FAN. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XHIBIT CENTRAL STATION WAS NO LONGER REPAIRABLE. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24488951 ↗
  • MalfunctionMar 2, 2026Unexpected Shutdown

    THE CUSTOMER CALLED SPACELABS HEALTHCARE TO REPORT THE XHIBIT CENTRAL STATION (XCS) UNEXPECTEDLY SHUTDOWN. NO PATIENT OR USER HARM WAS REPORTED. THE SPACELABS HEALTHCARE FIELD SERVICE ENGINEER (FSE) FOUND THE XCS WAS HOT TO THE TOUCH. THE FSE CLEANED THE CPU, CONFIGURED THE DISPLAYS, AND PERFORMED CALIBRATION OF THE TOUCH SCREENS. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE UNIT WAS RETURNED TO SERVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24483981 ↗
  • MalfunctionFeb 13, 2026No Audible Alarm

    THE CUSTOMER CONTACTED SPACELABS TECHNICAL SUPPORT TO REPORT THAT THEIR XHIBIT CENTRAL STATION (XCS) LOST AUDIBLE ALARMS. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. IN AN ATTEMPT TO RESOLVE THE LOSS OF AUDIO, THE BIOMED RESTARTED THE DEVICE. FOLLOWING THE RESTART, THE LICENSE WAS LOST ON THE XCS. A FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO RELICENSE THE DEVICE AND TROUBLESHOOT THE LOSS OF AUDIO. THE FSE DISCONNECTED A CABLE THAT WAS CONNECTING A PC TO THE XCS AND RE-LICENSED THE XCS. FOLLOWING THE LICENSE RESOLUTION, THE FSE REPORTED THAT THE UNIT PASSED ALL FUNCTIONAL TESTING AND WAS RETURNED TO SERVICE. CAUSE OF THE REPORTED FAILURE WAS NOT DETERMINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24339714 ↗
  • MalfunctionJan 21, 2026Communication or Transmission Problem

    IT WAS REPORTED TO SPACELABS HEALTHCARE THAT AN XHIBIT CENTRAL STATION WAS OFFLINE. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. A SPACELABS TECHNICAL SUPPORT REPRESENTATIVE WALKED THE USER THROUGH PERFORMING A REBOOT OF THE XHIBIT CENTRAL STATION. FOLLOWING THE REBOOT, THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. CAUSE OF FAILURE WAS NOT DETERMINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24141443 ↗
  • MalfunctionDec 19, 2025No Display/Image; No Display/Image

    THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT TWO DISPLAYS ON A XHIBIT CENTRAL STATION (XCS) WENT BLANK WHILE MONITORING TELEMETRY PATIENTS. SPACELABS HEALTHCARE TECHNICAL SUPPORT ASSISTED THE CUSTOMER IN TROUBLESHOOTING THE XCS AND THE ISSUE WAS TRACED DOWN TO FAULTY DISPLAY CABLES. ONCE THE DISPLAY CABLES WERE REPLACED, THE CUSTOMER CONFIRMED THE DISPLAYS WERE NOW FUNCTIONING PROPERLY. THE FAILURE WAS DUE TO BAD DISPLAY CABLES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23854474 ↗
  • MalfunctionDec 11, 2025Unexpected Shutdown; Unexpected Shutdown

    THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS, THEIR XHIBIT CENTRAL STATION (XCS) HAD "GONE DOWN". THE CUSTOMER CLARIFIED THAT THE XCS HAD NO VIDEO OUTPUT AND THE POWER INDICATOR WOULD RANDOMLY BLINK. THE PATIENTS WERE MOVED TO A DIFFERENT CENTRAL STATION AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER RETURNED THEIR DEVICE TO THE SPACELABS HEALTHCARE EQUIPMENT SERVICE CENTER (ESC) FOR EVALUATION. THE ESC TECHNICIAN EVALUATED THE DEVICE WHERE IT WAS FOUND THAT THE DEVICE HAD A FAULTY POWER SUPPLY ASSEMBLY. IT WAS ALSO FOUND THAT THE FAN ON THE VIDEO CARD WAS NOT FUNCTIONAL. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XCS WAS NO LONGER REPAIRABLE, AND THAT THEY WOULD NEED TO REPLACE THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23785934 ↗
  • MalfunctionDec 10, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

    THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS, THE XHIBIT CENTRAL STATION (XCS) WOULD FREEZE. THE CUSTOMER SENT THE DEVICE TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. AT THIS TIME THE DEVICE HAS NOT BEEN EVALUATED. 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 23769648 ↗
  • MalfunctionNov 26, 2025No Display/Image; No Display/Image

    THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS, ONLY WAVEFORMS WERE DISPLAYING. ALL OTHER INFORMATION WAS NO LONGER SHOWING ON THE DISPLAY, INCLUDING ALARM AND WARNING MESSAGES. A SPACELABS TECHNICAL SUPPORT REPRESENTATIVE WALKED THE USER THROUGH PERFORMING A RESTART OF THE XHIBIT CENTRAL STATION. FOLLOWING THE REBOOT, THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. CAUSE OF FAILURE WAS NOT DETERMINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23660651 ↗
  • MalfunctionNov 20, 2025No Display/Image; No Display/Image

    A CUSTOMER BIOMED CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT WHILE MONITORING A TELEMETRY PATIENT ON A XHIBIT CENTRAL STATION (XCS), THE DISPLAY WENT BLANK. THE BIOMED STATED THAT THE PATIENT WAS MOVED TO DIFFERENT CENTRAL STATION TO RESUME MONITORING. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. THE BIOMED REPORTED THAT THEY HAD ATTEMPTED TO SWAP THE DISPLAY AND DISPLAY PORT CABLE, HOWEVER THE ISSUE PERSISTED. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS PAGED TO ASSIST WITH FURTHER TROUBLESHOOTING. THE FSE CONTACTED THE CUSTOMER AND WALKED THE CUSTOMER THROUGH TROUBLESHOOTING THE DISPLAY. THE CUSTOMER REPORTED AFTER RESEATING THE DISPLAY PORT CONNECTIONS ON BOTH THE DISPLAY AND XCS, THE DISPLAY RETURNED. THE CUSTOMER CALLED SPACELABS HEALTHCARE BACK ON (B)(6) 2025 AND REPORTED THAT THE FAILURE OCCURRED AGAIN HOWEVER THE SECOND INSTANCE THE ISSUE RESOLVED ON ITS OWN. THE CUSTOMER REQUESTED THE DEVICE BE EVALUATED AND REPAIRED AS NEEDED BY THE EQUIPMENT SERVICE CENTER. 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 23609591 ↗
  • MalfunctionSep 17, 2025Unexpected Shutdown; Unexpected Shutdown

    THE CUSTOMER CALLED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT A XHIBIT CENTRAL STATION (XCS) WOULD POWER ITSELF OFF AFTER APPROXIMATELY TEN MINUTES OF USE. THE UNIT WAS REMOVED FROM SERVICE AND SENT IN FOR DEPOT REPAIR. THE DEVICE WAS RECEIVED AND EVALUATED BY AN EQUIPMENT SERVICE CENTER TECHNICIAN WHO VERIFIED THE REPORTED PROBLEM AND IDENTIFIED THE ISSUE WAS A RESULT OF OVERHEATING DUE TO A MALFUNCTIONING FAN ON THE VIDEO CARD. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XHIBIT CENTRAL STATION WAS NO LONGER REPAIRABLE. THE CUSTOMER ACCEPTED THE OFFER OF A REPLACEMENT UNIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23080595 ↗
  • MalfunctionAug 8, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

    THE CUSTOMER REPORTED THAT THEIR XHIBIT CENTRAL STATION (XCS) HAD BECOME FROZEN. A SPACELABS TECHNICAL SUPPORT REPRESENTATIVE WALKED THE USER THROUGH PERFORMING A HARD REBOOT OF THE XHIBIT CENTRAL STATION. FOLLOWING THE REBOOT, THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. CAUSE OF FAILURE WAS NOT DETERMINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22755889 ↗
  • MalfunctionJul 18, 2025Unexpected Shutdown; Unexpected Shutdown

    THE CUSTOMER REPORTED THAT WHILE MONITORING TELEMETRY PATIENTS ON A XHIBIT CENTRAL STATION (XCS) THE CENTRAL SUDDENLY POWERED OFF. THE CUSTOMER REPORTED THAT THEY TURNED THE UNIT BACK ON AND SEEMED TO BE FUNCTIONING. THE ISSUE WAS ESCALATED TO THE INTERNAL BIOMED TEAM. IN A FOLLOW UP CALL, IT WAS CONFIRMED THAT A BIOMED INSPECTED THE SYSTEM AND FOUND THAT THE UNIT WAS OVERHEATING. THE UNIT WAS CLEANED OUT AND HAS SINCE BEEN WORKING WITH NO FURTHER ISSUES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22549510 ↗
  • MalfunctionJul 11, 2025Unexpected Shutdown; Unexpected Shutdown

    THE CUSTOMER REPORTED THAT A XHIBIT CENTRAL STATION (XCS) WAS POWERING ITSELF OFF AFTER THIRTY MINUTES. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER CONTACTED THE CUSTOMER, A BIOMEDICAL ENGINEER, TO ASSIST WITH TROUBLESHOOTING. THE BIOMED FOUND A BROKEN HEAT SINK AND A FAULTY POWER SUPPLY ASSEMBLY. THE BIOMED REPLACED THE FAULTY POWER SUPPLY, HEAT SINK, AND HEAT SINK FAN. AFTER REPAIR, IT WAS FOUND THAT THE DEVICE WOULD NOT BOOT UP. A FIELD SERVICE ENGINEER WAS DISPATCHED FOR ADDITIONAL INVESTIGATION. THE FSE VERIFIED THE ISSUE AND CONTINUED TO REINSTALL THE DEVICE SOFTWARE. AFTER OBSERVING PROPER DEVICE OPERATION, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22487802 ↗
  • MalfunctionJul 10, 2025No Display/Image; No Display/Image

    THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS, THE XHIBIT CENTRAL STATION LOST VIDEO SIGNAL. THE CUSTOMER TRIED TO USE DIFFERENT VIDEO PORTS BUT COULD NOT GET THE VIDEO TO REMAIN UP. THE DEVICE WAS SHIPPED TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. FOLLOWING THE DEVICE EVALUATION, IT WAS DETERMINED THAT FAN ON THE VIDEO CARD WAS NO LONGER FUNCTIONAL. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XHIBIT CENTRAL STATION WAS NO LONGER REPAIRABLE, AND THAT THEY WOULD NEED TO REPLACE THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22476010 ↗
  • MalfunctionJun 20, 2025Unexpected Shutdown; Unexpected Shutdown

    THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS ON A XHIBIT CENTRAL STATION (XCS), THE CENTRAL STATION WOULD SHUT DOWN ON ITS OWN WHILE IN USE. THE CUSTOMER SHIPPED THE DEVICE IN FOR REPAIR AND IT WAS EVALUATED BY A EQUIPMENT SERVICE CENTER TECHNICIAN. THE TECHNICIAN STATED THAT THE UNIT HAD A LOT OF DUST BUILT UP IN THE UNIT AND THE FAN ON THE VIDEO CARD WAS NON-FUNCTIONAL. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XHIBIT CENTRAL STATION WAS NO LONGER REPAIRABLE. A REPLACEMENT UNIT WAS PROVIDED TO THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22294660 ↗
  • MalfunctionMay 30, 2025Unexpected Shutdown; Unexpected Shutdown

    THE CUSTOMER REQUESTED REPAIR OF A XHIBIT CENTRAL STATION (XCS) THAT SHUT DOWN WHILE IN USE DUE TO A FAULTY FAN ON THE VIDEO CARD. THE UNIT WAS RECEIVED BY SPACELABS HEALTHCARE AND THE REPORTED PROBLEM WAS VERIFIED. THE CUSTOMER WAS ADVISED THAT DUE TO THE AGE OF THEIR DEVICE AND PART OBSOLESCENCE THEIR XHIBIT CENTRAL STATION WAS NO LONGER REPAIRABLE, AND THAT THEY WOULD NEED TO REPLACE THE DEVICE. THE CUSTOMER APPROVED THE OFFER OF THE REPLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22117187 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122146. One submission often covers many models, so check the product and lot details in each record.

  • Z-2916-2026 · Jun 4, 2026 · Open, Classified
    Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central S
  • Z-0332-2017 · Oct 18, 2016 · Terminated
    Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to network
  • Z-2885-2016 · Aug 25, 2016 · Terminated
    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient
  • Z-1092-2016 · Feb 26, 2016 · Terminated
    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs H

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.