BEUDAMED
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    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·May 8, 2015

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code MHX·October 17, 2013

    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·February 26, 2016

    Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code DQA·May 9, 2014

    Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·August 25, 2016

    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·August 25, 2016

    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd.·Product code CBK·March 5, 2015

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code DSI·April 17, 2015

    Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Inc.·Product code MHX·August 30, 2019

    91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code DSI·July 1, 2016

    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MSX·January 17, 2018

    Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·October 18, 2016

    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 physiologic monitors via Flexport interfaces.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·June 6, 2014

    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Inc.·Product code DQK·January 28, 2019

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·January 28, 2015

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·January 28, 2015

    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code CBR·June 18, 2014

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code DXH·September 3, 2015

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·July 2, 2014

    The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MHX·March 28, 2016