McKesson Cardiology" Hemo 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 8, 2014).
- Recall Initiated
- August 27, 2014
- Posted
- October 8, 2014
- Terminated
- May 18, 2016
- Recall Number
- Z-0042-2015
- Quantity
- 272 devices
- Firm Location
- Information Technology Business Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Distribution
Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.
Lot / Code Info
McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.
Root Cause
Software design (manufacturing process)
Action Taken
On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.