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Recall Observatory FDA recall evidence

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

August 27, 2014

Class II

Product summary

Firm
Mckesson Information Solutions LLC
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

    reason.device_software_design · v1.0.0

    Software Error