Safety Alert for Anesthesia Care System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by McKesso.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-03-13
  • Event Date Posted
    2014-03-13
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: mckesson anesthesia care system the u.S. food and drug administration (fda) posted a medical device safety alert concerning mckesson anesthesia care system with code number mac 14.3.1/mac 14.3.1.1. 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 in that it included data from another case. for details, please refer to the fda website:http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1060-2014&w=03122014&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 march 2014.

Device

  • Model / Serial
  • Product Classification
  • Product Description
    Medical Device Safety Alert: McKesson Anesthesia Care System
  • Manufacturer

Manufacturer