Nihon Kohden America Inc - CNS6200 Series Central Nurse Station - Class 2 Recall
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 Product Usage: The CNS-6200 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and/or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit. This product will be available for use by medical personnel on all patient populations within a medical facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2014 Category: Medical Equipment Source Type: alerts
Spacelabs Healthcare Inc - Ultraview SL Command Module - Class 2 Recall
Spacelabs Medical Ultraview SL" Command Module, Model 91496. Detector and alarm, arrhythmia. 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 (SpO2) and cardiac output. Acquired data may then be communicated to an information network...
Source: Medical Device Recalls - June 4, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. - Class 2 Recall
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive bloo...
Source: Medical Device Recalls - March 12, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - CARESCAPE Monitor B850 - Class 2 Recall
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (F...
Source: Medical Device Recalls - February 5, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. - Class 2 Recall
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, car...
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts
Karl Storz Endoscopy America Inc - Broncho Flexible Fiberscope - Class 2 Recall
Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 - Class 2 Recall
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric n...
Source: Medical Device Recalls - December 13, 2013 Category: Medical Equipment Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - V Series Monitor, Mindray DS USA, Inc - Class 2 Recall
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performin...
Source: Medical Device Recalls - November 26, 2013 Category: Medical Equipment Source Type: alerts
Spacelabs Healthcare, Llc - Spacelabs Healthcare qube Compact Patient Monitor, Model 91390 - Class 2 Recall
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 supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2013 Category: Medical Equipment Source Type: alerts
Spacelabs Healthcare, Llc - Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S - Class 2 Recall
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2013 Category: Medical Equipment Source Type: alerts
Boston Scientific CRM Corp - Boston Scientific TELIGEN ICD - Class 2 Recall
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 18, 2013 Category: Medical Equipment Source Type: alerts
Boston Scientific CRM Corp - Boston Scientific COGNIS CRTD - Class 2 Recall
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 18, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - CARESCAPE Monitor 650 - Class 2 Recall
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature a...
Source: Medical Device Recalls - September 20, 2013 Category: Medical Equipment Source Type: alerts
BRAEMAR, INC. - Lithium Thionyl nonrechargeable disposable battery pack - Class 2 Recall
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2013 Category: Medical Equipment Source Type: alerts
BRAEMAR, INC. - Lithium Thionyl nonrechargeable disposable battery pack - Class 2 Recall
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2013 Category: Medical Equipment Source Type: alerts
