Events

Recall of Device Recall McKesson Cardiology Hemo System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mckesson Information Solutions LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69377
  • Event Risk Class
    Class 2
  • Event Number
    Z-0042-2015
  • Event Initiated Date
    2014-08-27
  • Event Date Posted
    2014-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130364
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    Software error: the mckesson cardiology hemo calculation section incorrectly converts the hemoglobin value before it is utilized in the applicable formula calculations.
  • Action
    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.

Device

Device Recall McKesson Cardiology Hemo System
  • Model / Serial
    McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
  • Manufacturer
    Mckesson Information Solutions LLC

Manufacturer

Mckesson Information Solutions LLC
  • Manufacturer Address
    Mckesson Information Solutions LLC, 5995 Winward Plaza, Information Technology Business, Alpharetta GA 30005
  • Source
    USFDA