Spacelabs Healthcare Qube Compact Monitor (91390

• 3 recalls, same reason

  • Ongoing Z-0169-2026 FDA Class II ·initiated 5 Sep 2025
  • Ongoing Z-0167-2026 FDA Class II ·initiated 5 Sep 2025
  • Ongoing Z-0168-2026 FDA Class II ·initiated 5 Sep 2025

  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.

• • Terminated Z-1608-2015 FDA Class II ·initiated 8 May 2015

  The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).

• • Terminated Z-1145-2015 FDA Class II ·initiated 28 Jan 2015

  Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.

• • Terminated Z-1852-2014 FDA Class II ·initiated 6 Jun 2014

  Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.

• • Terminated Z-0351-2014 FDA Class II ·initiated 17 Oct 2013

  Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.

• • Terminated Z-0188-2014 FDA Class II ·initiated 17 Oct 2013

  Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

• • Terminated Z-0403-2013 FDA Class II ·initiated 19 Oct 2012

  Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short.

510(k) Number

K120616 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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