Events

Recall of Device Recall McKesson Anesthesia Care System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MCKESSON TECHNOLOGIES INC..

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
    66287
  • Event Risk Class
    Class 1
  • Event Number
    Z-1060-2014
  • Event Initiated Date
    2013-03-15
  • Event Date Posted
    2014-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121944
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    There was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record (acr) in that it included data from another case.
  • Action
    McKesson sent a Clinical Alert dated March 15, 2013 to all affected customers. Additionally, phone calls were placed to each customer, followed up by an email to provide them written copies of the communication and Clinical Alert and obtaining acknowledgement that they have read and understand the issue and preventive actions to take. Customers with questions were instructed to contact McKesson Customer Support at 800-442-6767 (option 3). For questions regarding this recall call 404-338-3556.

Device

Device Recall McKesson Anesthesia Care System
  • Model / Serial
    MAC 14.3.1/MAC 14.3.1.1
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
  • Product Description
    McKesson Anesthesia Care || Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.
  • Manufacturer
    MCKESSON TECHNOLOGIES INC.

Manufacturer

MCKESSON TECHNOLOGIES INC.
  • Manufacturer Address
    MCKESSON TECHNOLOGIES INC., 300 West Morgan St, STE 200, Durham NC 27701
  • Source
    USFDA