XprezzonRecalls & reported problems across all models

We found 2 models of Xprezzon by Spacelabs Healthcare (Washington), Inc in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2025 and Mar 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

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

Xprezzon 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 Xprezzon problems

Xprezzon models

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

• Xprezzon Xprezzon Monitor

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  3 recalls3 reports
• Xprezzon Xprezzon Monitor

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

Recent Xprezzon adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026No Audible Alarm

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT A XPREZZON BEDSIDE MONITOR NO LONGER HAD AUDIO. NO PATIENT OR USER HARM WAS REPORTED IN ASSOCIATION WITH THE EVENT. DURING TROUBLESHOOTING IT WAS IDENTIFIED THAT THE AUDIO ON/OFF TOGGLE BUTTONS WERE GRAYED OUT. TECHNICAL SUPPORT WALKED THE USER THROUGH CHANGING THE ALARM AUDIO LEVELS; HOWEVER, THE ALARM TONES WERE STILL INAUDIBLE. AFTER THE BIOMED SWAPPED OUT THE COMMAND MODULE AND RESTARTED THE XPREZZON BEDSIDE MONITOR THE DEVICE WOULD OPERATE AS EXPECTED. IT WAS ALSO LATER CONFIRMED THAT THE ORIGINAL MODULE WOULD WORK AS EXPECTED WHEN INSERTED IN THE MONITOR AGAIN. WHILE THE REPORTED PROBLEM WAS RESOLVED, THE CAUSE OF THE FAILURE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719984 ↗
• MalfunctionFeb 11, 2026Communication or Transmission Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TECHNICAL SUPPORT TO REPORT THAT A XPREZZON BEDSIDE MONITOR WAS FREQUENTLY APPEARING OFFLINE AT THE XHIBIT CENTRAL STATION AND WOULD STOP WORKING IN THE ROOM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE DEVICE WOULD COME BACK UP, BUT WOULD REQUIRE THE PATIENT TO BE READMITTED. SPACELABS TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT THE SYMPTOMS INDICATE A POSSIBLE POWER RELATED ISSUE AND ADVISED THAT HAVE THEIR BIOMED DEPARTMENT EVALUATE THE DEVICE. IN A FOLLOW UP CALL WITH THE CUSTOMER, THE CUSTOMER CONFIRMED THAT NO FURTHER ISSUES WERE OBSERVED WITH THE DEVICE AND THEY WERE UNAWARE OF ANY ADDITIONAL INFORMATION. CAUSE OF FAILURE COULD NOT BE DETERMINED DUE TO LACK OF INFORMATION. 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 24318772 ↗
• MalfunctionDec 16, 2025Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT WHILE MONITORING A PATIENT AN XPREZZON BEDSIDE MONITOR SHUT DOWN, WOULD NOT BOOT BACK UP, AND WOULD EMIT A CONSTANT BEEPING TONE. THE CUSTOMER SHIPPED THE UNIT TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. THE UNIT WAS EVALUATED BY AN EQUIPMENT SERVICE CENTER TECHNICIAN WHO VERIFIED THE REPORTED FAILURE. THE ISSUE WAS IDENTIFIED TO BE A RESULT OF A FAULTY VIDEO PCBA. THE UNIT WAS REPAIRED BY THE TECHNICIAN AND RETURNED TO THE CUSTOMER. THE ISSUE WAS DUE TO A FAULTY VIDEO PCBA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824267 ↗
• MalfunctionSep 12, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER PROVIDED AN EXPORT OF WORK ORDERS THAT INCLUDED ALLEGED SPACELABS HEALTHCARE PRODUCT MALFUNCTIONS. THE FOLLOWING INFORMATION WAS PROVIDED: SPACELABS MONITOR IS FROZEN. THE BIOMED INSTALLED A LOANER UNIT TO RESOLVE THE IMMEDIATE ISSUE. THE DEVICE WAS REPAIRED ON SITE BY THE BIOMED BY REPLACING THE DISPLAY ASSEMBLY. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION ABOUT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045728 ↗
• MalfunctionJul 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR XPREZZON BEDSIDE MONITOR HAD CRASHED WHILE IN USE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE BIOMEDICAL ENGINEER HAD CONFIRMED THAT THE DEVICE WAS FAILING THE POWER ON SELF TEST FOR A DRAM ISSUE PRIOR TO PUTTING THE UNIT INTO USE, BUT THEY HAD PUT IT INTO SERVICE REGARDLESS. THE DEVICE HAS SINCE BEEN REMOVED FROM SERVICE AND WILL BE RETURNED TO SPACELABS HEALTHCARE FOR ADDITIONAL INVESTIGATION. AT THIS TIME 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 22476009 ↗

Other Spacelabs Healthcare (Washington), Inc products

• Xhibit3 models · 272 reports · 1 recall
• qube2 models · 24 reports · 3 recalls
• Ultraview SL2 models · 5 reports · 2 recalls