Reported Oct 29, 2014 · Terminated
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring,…
Mckesson Information Solutions LLC
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 Information Solutions LLC · 5995 Winward Plaza · Alpharetta, GA · 30005
Is this the product you have?
- McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Lot codes and dates
- McKesson Cardiology TM Hemo versions
11.0HF511.111.1SP511.1SP611.1SP6HF111.1SP6HF312SP112.112.1HF112.1HF212.212.2HF112.2HF212.2HF312.2HF4
- McKesson Cardiology TM Hemo versions
- Amount recalled
- 625 devices
Where it was sold
- Nationwide
Why it was recalled
McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i
This product could cause temporary or reversible health problems — stop using it.
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