qube miniRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841522100239), received between Dec 19, 2024 and Feb 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (3 reports).

9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Power Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEIR QUBE MINI WOULD INTERMITTENTLY SHUT DOWN WHILE IN USE ON A PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. THE CUSTOMER SHIPPED THE UNIT TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. THE DEVICE WAS EVALUATED BY AN EQUIPMENT SERVICE CENTER TECHNICIAN AND THE REPORTED PROBLEM WAS NOT VERIFIED. HOWEVER, THE TECHNICIAN REPORTED THAT THE CPU PCBA HAD AN INCONSISTENT POWER SUPPLY THAT CAUSED ISSUES WITH BATTERIES PROPERLY CHARGING. THE DEVICE WAS REPAIRED AND AFTER PASSING ALL FINAL FUNCTIONAL TESTING, THE UNIT WAS RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229085 ↗
• MalfunctionDec 10, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT A QUBE MINI BEDSIDE MONITOR HAD SHUT OFF ON ITS OWN WHILE MONITORING A PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR FURTHER EVALUATION. THE EQUIPMENT SERVICE CENTER (ESC) TECHNICIAN EVALUATED THE DEVICE AND WAS ABLE TO VERIFY THE REPORTED ISSUE. THE ESC TECHNICIAN FOUND THAT THE UNIT HAD A FAULTY CPU PCBA. THE FAULTY BOARD WAS REPLACED AND AFTER PASSING ALL FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A FAULTY CPU PCBA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769637 ↗
• MalfunctionAug 8, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE QUBE MINI WOULD RANDOMLY POWER ITSELF OFF AND FAILS TO PRODUCE THE FAIL-SAFE ALARM TONE TO NOTIFY STAFF OF THE POWER LOSS. THE UNIT WAS REMOVED FROM USE AND THE BIOMED COULD NOT TURN THE UNIT BACK ON. A DEPOT REPAIR REQUEST WAS CREATED TO REPAIR THE UNIT. AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED BY SPACELABS HEALTHCARE. 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 22755867 ↗
• MalfunctionDec 19, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE PERFORMING CHEST COMPRESSIONS ON A PATIENT, THE QUBE BEDSIDE MONITOR SUDDENLY POWERED DOWN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THE REPORTED FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20983517 ↗

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-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-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-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-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-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.