Device product
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-0042-2015
Product summary
- Event
- Event 69377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 272 devices
- Official record key
device-enforcement:Z-0042-2015
Official wording
Reason: Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Code information: McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
Software Error