Events

Safety Alert for Continuum MR Infusion System - Pump

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

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
    2014-03-26
  • Event Date Posted
    2014-03-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140326a.html
  • 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: medrad continuum mr infusion system - pump health canada has issued a medical device safety alert concerning continuum mr infusion system - pump, manufactured by medrad inc. the affected lot numbers are 3008236, 3009135, 3009917 and 3009966. the manufacturer has identified that there have been incidents resulting in magnetic attraction caused by a damaged locking pin. the locking pin is found in the pump retaining bracket and is used to securely hold the pump in the bracket in the mr environment. the manufacturer has advised users to cease use of affected products immediately and remove the product from the mr scan room. for details, please visit the following health canada website:http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38611r-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 march 2014.

Device

Continuum MR Infusion System - Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medrad Continuum MR Infusion System - Pump
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DH