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
    119525
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-25
  • 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
    It was identified that during an injection there is a potential that a saline phase could not complete if the injection is started or resumed while a keep vein open (kvo) pulse is active. additionally a software revistion will be implemented to adjust the reminder behavior to ensure that if the injection phase is paused mannually the reminder timer resumes once the injection phase is resumed.

Device

MRXPERION MR INJECTION SYSTEM
  • Model / Serial
    Model Catalog: MRXP 200 (Lot serial: Serial number 100029)
  • 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