Xprezzon Xprezzon Monitor (REF 91393)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841522100079), received between Jul 10, 2025 and Dec 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

7 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗

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-0169-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to
• Z-0167-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to D
• Z-0168-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to
• 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