McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
This recall has been terminated (originally issued October 20, 2014).
- Recall Initiated
- June 25, 2014
- Posted
- October 20, 2014
- Terminated
- October 26, 2017
- Recall Number
- Z-0093-2015
- Quantity
- 625 devices
- Firm Location
- Information Technology Business Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.
Lot / Code Info
McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.
Root Cause
Labeling design
Action Taken
Consignees were notified via Field Safety Notice on 06/25/2014.