21 results
·
49ms
·
Sources: EU EUDAMED, US FDA
HORIZON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD·Product code DQK·January 28, 2010
HORIZON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD·Product code DQK·April 1, 2010
HORIZON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code DQK·January 9, 2012
MCKESSON CARDIOLOGY
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code LLZ·August 13, 2015
HORIZON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code DQK·November 6, 2009
HORIZON CARDIOLOGY HEMO
FDA Adverse Event
Other
·MCKESSON ISRAEL LTD.·Product code DQK·April 22, 2009
MCKESSON CARDIOLOGY ECG MANAGEMENT
FDA Adverse Event
Injury
·MCKESSON ISRAEL LTD.·Product code DQK·August 12, 2020
MCKESSON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code MWI·July 10, 2014
MCKESSON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code DQK·August 26, 2014
MCKESSON CARDIOLOGY HEMO
FDA Adverse Event
Death
·MCKESSON ISRAEL LTD.·Product code DQK·August 19, 2016
CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code DQK·February 20, 2020
MCKESSON CARDIOLOGY HEMO
FDA Adverse Event
Malfunction
·MCKESSON ISRAEL LTD.·Product code DQK·March 16, 2015
MCKESSON CARDIOLOGY HEMO
FDA Adverse Event
Death
·MCKESSON ISRAEL LTD.·Product code MWI·June 20, 2016
Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
FDA Recall
Terminated
·McKesson Provider Technologies·Product code DQK·November 12, 2007
HORIZON CARDIOLOGY
FDA Adverse Event
Malfunction
·MCKESSON INFORMATION SOLUTIONS LLC, MCKESSON ISRAEL LTD·Product code DQK·June 2, 2010
Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
FDA Recall
Terminated
·McKesson Provider Technologies Medical Imaging Group·Product code DQK·January 27, 2010
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Recall
Terminated
·McKesson Israel Ltd. Or Towers Bldg. B 4, Nehoshet St. Tel Aviv Israel·Product code DQK·March 12, 2018
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
FDA Enforcement
Class II
·Terminated·McKesson Israel Ltd.·January 14, 2015
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Enforcement
Class II
·Terminated·McKesson Israel Ltd.·September 12, 2018
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
FDA Recall
Terminated
·McKesson Israel Ltd. 4 Nehoshet St., or Towers Bldg. B Tel Aviv Israel·Product code DQK·December 19, 2014