Xprezzon Xprezzon Monitor (REF 91393)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841522131479), received between Sep 12, 2025 and Mar 30, 2026 — classified as 3 malfunctions.

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

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

4 other recalls cover devices cleared under the same FDA submission (K112962); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 5, 2025Class IIOpen, 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 ↗

2. Sep 5, 2025Class IIOpen, 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, 2025Class IIOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112962. One submission often covers many models, so check the product and lot details in each record.

• Z-1144-2015 · Jan 28, 2015 · Terminated
  Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Fle
• Z-0196-2013 · Oct 5, 2012 · Terminated
  The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth wit
• Z-2019-2012 · Jun 12, 2012 · Terminated
  Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzo
• Z-1705-2012 · May 22, 2012 · Terminated
  Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacela