Home / Recalls / Mckesson Information Solutions LLC / Z-0042-2015

Z-0042-2015 Class II Terminated

Recalled by Mckesson Information Solutions LLC — Alpharetta, GA

Recall Details

Product Type: Devices
Report Date: October 15, 2014
Initiation Date: August 27, 2014
Termination Date: May 18, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 272 devices

Product Description

McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

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 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.

Code Information

McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.