Device product
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.
Z-2968-2018
Product summary
- Event
- Event 80723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31 units
- Official record key
device-enforcement:Z-2968-2018
Official wording
Reason: Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Code information: software versions: 13.0 HF1, 13.0HF2, 13.0HF3
Distribution pattern: US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.
Derived failure modes
-
Unknown
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.