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Sources: EU EUDAMED, US FDA
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FDA Recall
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Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.
FDA Recall
Terminated
·McKesson Provider Technologies Medical Imaging Group·Product code DQK·April 15, 2010
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
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
FDA Recall
Open, Classified
·CHANGE HEALTHCARE CANADA COMPANY·Product code DQK·February 10, 2020
Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
FDA Recall
Terminated
·McKesson Provider Technologies Medical Imaging Group·Product code DQK·June 16, 2010