Boston Scientific Corporation - CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System - Class 2 Recall
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologi...
Source: Medical Device Recalls - June 19, 2015 Category: Medical Equipment Source Type: alerts
Mortara Instrument, Inc - ELI 380 Electrocardiograph - Class 2 Recall
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 13, 2015 Category: Medical Equipment Source Type: alerts
Leonhard Lang Medizintechnik GmbH - Skintact ECG Electrode FS50, Stable Base ECG Electrode SBT60 - Class 2 Recall
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 29, 2015 Category: Medical Equipment Source Type: alerts
Alivecor SFO - AliveECG App Version 2.1.2 used with AliveCor Heart Monitor - Class 3 Recall
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2015 Category: Medical Equipment Source Type: alerts
Philips Medical Systems, Inc. - Philips IntelliSpace ECG Management System - Class 2 Recall
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 - Class 2 Recall
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module 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 professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general...
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Solar 8000 and Transport Pro with Patient Data Module (Marketed as CARESCAPE Patient Data Module) - Class 2 Recall
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module 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 professional medical facility, such as hospital, clinic,...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Dash 3000/4000/5000 Patient Monitor - Class 2 Recall
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited ...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts
Physio Control, Inc. - LIFEPAK 500 Automated External Defibrillator (AED) - Class 2 Recall
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2013 Category: Medical Equipment Source Type: alerts
