5 results
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46ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Hemo
FDA Enforcement
Class II
·Terminated·Change Healthcare Israel Ltd.·June 5, 2019
Horizon Cardiology Hemo
FDA Enforcement
Class II
·Terminated·Change Healthcare Israel Ltd.·June 5, 2019
McKesson Cardiology Hemo
FDA Recall
Terminated
·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019
Horizon Cardiology Hemo
FDA Recall
Terminated
·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019