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.
Enforcement
- Recall Number
- Z-2968-2018
- Event ID
- 80723
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- McKesson Israel Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 12, 2018
- Initiation Date
- March 12, 2018
- Classification Date
- August 31, 2018
- Termination Date
- November 23, 2021
- Address
- Or Towers Bldg. B, 4, Nehoshet St., Tel Aviv, N/A, N/A, Israel
Description
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.
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
software versions: 13.0 HF1, 13.0HF2, 13.0HF3
US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.
31 units