Reported Sep 12, 2018 · Terminated
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing.…
McKesson Israel Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: McKesson Israel Ltd. · Or Towers Bldg. B · Tel Aviv, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- software versions
13.0 HF113.0HF213.0HF3
- software versions
- Amount recalled
- 31 units
Where it was sold
Why it was recalled
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
This product could cause temporary or reversible health problems — stop using it.
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