Events

Recall of MRXPERION MR INJECTION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER MEDICAL CARE 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
    131935
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    In october 2015 a customer complaint was received where it was reported that during a procedure a false button push occurred while the mrxperion injector was being used with a siemens skyra 3t scanner. it was found that the head user interface assembly was non-conforming due to inadequate/missing shielding applied to the graphic overlay layer of the laminated assembly manufactured by the supplier.

Device

MRXPERION MR INJECTION SYSTEM
  • Model / Serial
    Model Catalog: MRXP 200 (Lot serial: Serial Number 100054)
  • Product Description
    MRXPERION MR INJECTION SYSTEM
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Manufacturer Address
    INDIANOLA
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC