Spacelabs Healthcare Xprezzon Beside Monitor(9913930)

• 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-1144-2015 FDA Class II ·initiated 28 Jan 2015

  Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.

• • Terminated Z-0196-2013 FDA Class II ·initiated 5 Oct 2012

  Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.

• • Terminated Z-2019-2012 FDA Class II ·initiated 12 Jun 2012

  There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.

• • Terminated Z-1705-2012 FDA Not yet classified ·initiated 22 May 2012

  The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or involuntarily shut down.

510(k) Number

K112962 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Spacelabs Medical Model 90481 EEG Module

  Class II

  FDA 510(k) K932842 Active Cleared 2 Mar 1994

• Spacelabs Medical ECG Module (Model 90492)

  Class II

  FDA 510(k) K942058 Active Cleared 17 May 1995

• Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories Model-91842

  Class II

  FDA 510(k) K060900 Active Cleared 23 Jun 2006

• Spacelabs Medical Full Disclosure System, Model 91810

  Class II

  FDA 510(k) K063490 Active Cleared 15 Mar 2007

• Spacelabs Healthcare Qube Compact Monitor (91390 Open recall

  Class II

  FDA 510(k) K120616 Active Cleared 29 Mar 2012

• Spacelabs Medical Patient Monitors

  Class II

  FDA 510(k) K102422 Active Cleared 7 Dec 2010

See all devices from Spacelabs Medical, Inc. →