Recall Z-2019-2012— Spacelabs Healthcare, Llc

Name: FDA recall Z-2019-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Llc, initiated 2012-06-12, terminated 2012-11-28. It names one FDA 510(k) clearance: K112962. Product: Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.. Reason: 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..

Recalling firm: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Terminated: 2012-11-28
Firm location: Issaquah, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)Spacelabs Medical, Inc.·cleared 2011-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.