Events

Recall of Device Recall McKesson Cardiology Hemo

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
    69380
  • Event Risk Class
    Class 2
  • Event Number
    Z-0093-2015
  • Event Initiated Date
    2014-06-25
  • Event Date Posted
    2014-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130368
  • 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
    Mckesson cardiology hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. mckesson has identified that its communication to customers regarding the required maintenance tests was insufficient. while each unit has an attached sticker i.
  • Action
    Consignees were notified via Field Safety Notice on 06/25/2014.

Device

Device Recall McKesson Cardiology Hemo
  • Model / Serial
    McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.
  • Product Description
    McKesson Cardiology Hemo. || McKesson Cardiology" Hemo is 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