Qube Qube Compact MonitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841522131455), received between Jan 31, 2025 and Dec 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Data Problem” (1 report).

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

6 other recalls cover devices cleared under the same FDA submission (K120616); 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-0169-2026 · 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-0168-2026 · 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.

• 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 ↗
• 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 ↗
• MalfunctionJan 31, 2025Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT WHILE IN USE, THE QUBE BEDSIDE MONITOR DISPLAYED AN ERROR MESSAGE "NO SIGNAL" ON THE BEDSIDE MONITOR. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120616. One submission often covers many models, so check the product and lot details in each record.

• Z-1608-2015 · May 8, 2015 · Terminated
  Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter
• Z-1145-2015 · Jan 28, 2015 · Terminated
  Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displ
• Z-1852-2014 · Jun 6, 2014 · Terminated
  Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other phy
• Z-0188-2014 · Oct 17, 2013 · Terminated
  Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
• Z-0351-2014 · Oct 17, 2013 · Terminated
  Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervi
• Z-0403-2013 · Oct 19, 2012 · Terminated
  qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.