Events

Recall of Device Recall McKesson Cardiology ECG Management

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by McKesson Israel Ltd..

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
    70144
  • Event Risk Class
    Class 2
  • Event Number
    Z-0910-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132318
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Reason
    An ecg procedure time stamp is incorrect, due to a software error in the mckesson cardiology ecg management with software versions 13.1 and 13.1.1.
  • Action
    McKesson sent an Urgent Field Safety Notice dated December 16, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed how to identify the potentially affected procedures and update the procedure date (if relevant) until a software update is made advailable for installation by McKesson. McKesson will proactively identify prior procedures affected by this issue and will notify customers of any issues identified. In addition to the Field Safety Notice, McKesson Israel will provide correction to the affected SW versions and will contact customers for deployment of a software patch that prevents this scenario from occurring. Customers with questions should contact McKesson Support at 1-866-777-0202. For questions regarding this recall call 404-338-3556.

Device

Device Recall McKesson Cardiology ECG Management
  • Model / Serial
    MC13.1 and MC13.1.1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
  • Product Description
    McKesson Cardiology ECG Management || It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
  • Manufacturer
    McKesson Israel Ltd.

Manufacturer

McKesson Israel Ltd.
  • Manufacturer Address
    McKesson Israel Ltd., 4 Nehoshet St., or Towers, Bldg. B, Tel Aviv Israel
  • Source
    USFDA