qubeRecalls & reported problems across all models

We found 2 models of qube by Spacelabs Healthcare (Washington), Inc in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2024 and Mar 2, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (12 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

qube recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 5, 2025Open, Classified

   Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

   Z-0169-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Sep 5, 2025Open, Classified

   Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

   Z-0168-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Sep 5, 2025Open, Classified

   Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

   Z-0167-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported qube problems

qube models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Qube Qube Compact Monitor

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  3 recalls3 reports
• qube 91390

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  21 reports

Recent qube adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A QUBE COMPACT MONITOR UNEXPECTEDLY SHUT DOWN AND NO LONGER POWERS UP. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION, AND THE ISSUE WAS VERIFIED. THE CAUSE OF THE ISSUE WAS FOUND TO BE THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE PCBA WAS REPLACED TO RESOLVE THE ISSUE. AFTER FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484336 ↗
• MalfunctionMar 2, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A QUBE COMPACT MONITOR SHUT DOWN WHILE MONITORING A PATIENT. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION, AND THE QUBE WOULD NOT POWER ON. THE CPU PCBA WAS REPLACED AND AFTER FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484248 ↗
• MalfunctionFeb 19, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEIR QUBE BEDSIDE MONITOR WAS INTERMITTENTLY REBOOTING ITSELF. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER'S DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION, AND THE REPORTED ISSUE WAS VERIFIED. THE CENTRAL PROCESSING UNIT PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED. AFTER FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397728 ↗
• MalfunctionFeb 5, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A QUBE COMPACT MONITOR SHUT DOWN WHILE MONITORING A PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PATIENT WAS MOVED TO A DIFFERENT BED FOR CONTINUED MONITORING AND THE DEVICE IN QUESTION WAS TAKEN OUT OF USE. THE CAUSE OF THE ISSUE WAS UNKNOWN AS THE CUSTOMER DECLINED FURTHER SERVICE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274863 ↗
• MalfunctionJan 21, 2026Communication or Transmission Problem

  THE CUSTOMER REPORTED TO SPACELABS HEALTHCARE THAT THE QUBE MONITOR SHUTS DOWN WHEN THE DEVICE IS MOVED. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE WHERE THE EQUIPMENT SERVICE CENTER FOUND A FAULTY SDLC PCBA. THE DEVICE WAS REPAIRED AND FOLLOWING ALL FUNCTIONAL TESTING, WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141442 ↗
• MalfunctionJan 16, 2026Unexpected Shutdown

  IT WAS REPORTED TO SPACELABS HEALTHCARE THAT A QUBE COMPACT MONITOR WOULD RANDOMLY TURN OFF AND RESTART. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RECEIVED BY SPACELABS HEALTHCARE FOR EVALUATION BUT THE INVESTIGATION IS NOT YET 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 24104854 ↗
• MalfunctionDec 11, 2025Power Problem; Power Problem

  THE CUSTOMER BIOMED REPORTED THAT USERS NOTIFIED HIM OF AN EVENT THAT OCCURRED AROUND 19:30 EST ON (B)(6) 2025 BEDSIDE MONITORS IN THEIR EMERGENCY ROOM DEPARTMENT WENT BLANK AND STAFF HAD TO RE-ADMIT ALL PATIENTS. IT WAS UNKNOWN HOW LONG THE OUTAGE LASTED AND THAT THERE WERE NO INCIDENTS THAT OCCURRED RELATED TO THE ISSUE. THE CUSTOMER STATED THEY WERE UNAWARE OF ANY POWER ISSUES. WHEN THE BIOMED ARRIVED ON SITE, THE DAYSHIFT STAFF STATED THAT THEY HAD NOT OBSERVED ANY ISSUES WITH DEVICES AND NO FAULTS WERE FOUND WHILE TESTING. THE NUMBER OF DEVICES WAS UNKNOWN, BUT THE BIOMED PROVIDED THE DETAILS OF ONE UNIT. THE BIOMED STATED THEY WERE JUST REPORTING THE INCIDENT AND NO FURTHER INFORMATION IS KNOWN. 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 23785942 ↗
• MalfunctionDec 8, 2025Power Problem; Power Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A XPREZZON BEDSIDE MONITOR THAT SHUT DOWN WHILE MONITORING A PATIENT DURING A SURGERY. THE CUSTOM REQUESTED A RETURN AUTHORIZATION TO RETURN THE FAULTY UNIT. AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED BY SPACELABS HEALTHCARE FOR FURTHER EVALUATION AND REPAIR. 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 23738747 ↗
• MalfunctionNov 20, 2025Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT THE SCREEN ON THEIR QUBE COMPACT MONITOR WOULD FREEZE AND UNEXPECTEDLY SHUT DOWN WHEN THE MONITOR WAS MOVED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. THE CUSTOMER RETURNED THEIR MONITOR TO THE EQUIPMENT SERVICE CENTER (ESC) FOR EVALUATION. AN ESC TECHNICIAN EVALUATED THE DEVICE WHERE THEY WERE ABLE TO VERIFY THE REPORTED ISSUE OF THE DEVICE SHUTTING DOWN, BUT THEY WERE UNABLE TO VERIFY THE REPORTED FREEZING DISPLAY. FURTHER EVALUATION OF THE DEVICE SHOWED THAT THE CAUSE OF THE REPORTED POWER ISSUE WAS DUE TO A FAULTY CPU PCBA. AFTER REPLACEMENT OF THE CPU PCBA, PROPER DEVICE OPERATION WAS OBSERVED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. THE CAUSE OF THE REPORTED POWER ISSUE WAS DUE TO A FAULTY CPU PCBA. THE CAUSE OF THE REPORTED SCREEN FREEZING ISSUE COULD NOT BE DETERMINED, AS THE ISSUE COULD NOT BE DUPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609585 ↗
• MalfunctionSep 3, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS, TWO XHIBIT CENTRAL STATIONS (XCS) WOULD RESTART UNEXPECTEDLY. THE CUSTOMER BIOMED PERFORMED TROUBLESHOOTING AND TRACED THE ISSUE TO A QUBE BEDSIDE MONITOR. WHEN THE BEDSIDE MONITOR WAS ADDED TO A ZONE ON THE XCS, THE XHIBIT SOFTWARE WOULD CRASH AND RESTART. ONCE THE MONITOR WAS REMOVED FROM USE, NO FURTHER ISSUES HAVE BEEN REPORTED. A PRODUCT SUPPORT SPECIALIST REQUESTED THE MONITOR BE SHIPPED TO SPACELABS HEALTHCARE FOR FURTHER EVALUATION. 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 22959853 ↗
• MalfunctionAug 28, 2025Complete Loss of Power; Complete Loss of Power

  THE CUSTOMER REPORTED THAT WHILE MONITORING A PATIENT, THE QUBE BEDSIDE MONITOR SUDDENLY SHUT DOWN. IT WAS CONFIRMED THAT THE QUBE BEDSIDE MONITOR EMITTED THE POWER SAFE ALARM THAT NOTIFIED THE STAFF OF THE ISSUE. THE CLINICIAN ADMITTED THE PATIENT TO A REPLACEMENT MONITOR AND SUBMITTED THE DEVICE TO THE INTERNAL BIOMED TEAM FOR REPAIR. IN A FOLLOW UP CALL, THE CUSTOMER BIOMED CONFIRMED THAT THE ISSUE WITH THE MONITOR WAS RESOLVED, HOWEVER DETAILS WERE UNKNOWN AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT IF THEY LEARNED OF ADDITIONAL INFORMATION, THEY WOULD FORWARD THE ADDITIONAL DETAILS. 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 22917285 ↗
• MalfunctionAug 8, 2025No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT WHILE TRANSPORTING A PATIENT, A QUBE BEDSIDE MONITOR DISPLAY TURNED OFF WHEN THE PORTABLE STAND WAS BUMPED. USERS POWER CYCLED THE DEVICE AND MOVED THE BATTERY TO A DIFFERENT BATTERY SLOT AND STATED THE DEVICE WAS ABLE TO RESUME MONITORING. DURING TROUBLESHOOTING THE ISSUE, IT COULD NOT BE DETERMINED IF THE ISSUE WAS LIMITED TO THE DISPLAY ONLY, OR IF THERE WAS A COMPLETE POWER LOSS. THE CUSTOMER REPORTED THAT A BIOMED EVALUATED THE DEVICE AND COULD NOT FIND ANY FAULTS WITH THE DEVICE. THE UNIT HAS BEEN PUT BACK IN USE WITH NO FURTHER ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755866 ↗
• MalfunctionJun 30, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT A QUBE BEDSIDE MONITOR GOT STUCK IN A BOOT LOOP WHILE MONITORING A PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FAULTY DEVICE WAS SHIPPED TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. THE DEVICE WAS RECEIVED AND EVALUATED BY AN EQUIPMENT SERVICE CENTER TECHNICIAN AND THE REPORTED PROBLEM WAS VERIFIED. THE FAILURE WAS TRACED DOWN TO A FAULTY CPU PCBA. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352735 ↗
• MalfunctionJun 30, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE IN USE A QUBE BEDSIDE MONITOR WOULD OCCASSIONALLY RESET AND REQUESTED EVALUATION AND REPAIR. CUSTOMER SERVICE MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO GENERATE A RMA TO HAVE THE DEVICE RETURNED FOR REPAIR. AT THIS TIME, THE CUSTOMER HAS NOT RESPONDED AND THE DEVICE HAS NOT BEEN RECEIVED. 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 22352698 ↗
• MalfunctionJun 20, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER BIOMED REPORTED THAT WHILE MONITORING A PATIENT, A QUBE BEDSIDE MONITOR SHUT DOWN. THE CUSTOMER REPORTED THE POWER LOSS ALARM FUNCTIONED TO NOTIFY CLINICAL STAFF OF THE SUDDEN SHUT DOWN AND THE PATIENT WAS MOVED TO ANOTHER ROOM. THE BIOMED STATED THE MONITOR WAS PLUGGED INTO AC MAINS AND THAT THE QUBE HAD A BATTERY INSIDE THAT WAS FULLY CHARGED. THE BIOMED ALSO REPORTED THAT THE MONITOR WOULD POWER DOWN WHEN THE BATTERY WAS REMOVED, EVEN WHILE CONNECTED TO MAINS. THE CUSTOMER STATED THAT THEY WOULD SHIP THE DEVICE IN FOR DEPOT REPAIR. AT THIS TIME, THE CUSTOMER HAS NOT OPENED A RMA TO SEND THE DEVICE IN FOR FURTHER EVALUATION. 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 22294658 ↗

Other Spacelabs Healthcare (Washington), Inc products

• Xhibit3 models · 272 reports · 1 recall
• Xprezzon2 models · 5 reports · 3 recalls
• Ultraview SL2 models · 5 reports · 2 recalls