Events

Recall of Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

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
    RC-2015-RN-00425-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00425-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Recent revisions of the device’s instructions for use (ifu) (part number 989803162691, rev. f- rev. h) inaccurately indicates that one of the temperature probe’s application sites is “endotracheal”. the application site should be listed as“esophageal”. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.. should the flextemp reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the flextemp temperature sensor or flextemp system jacket is left in the patient upon removal, or if the flextemp system jacket is damaged and sterilization compromised.
  • Action
    Philips is providing the customers with an errata sheet to the Expression IFU, which removes endotracheal as an application site. Philips is working on a solution to this issue and once a solution is available, Philips will provide the customers with another communication outlining the plans for implementing the solution. This action has been closed-out on 24/08/2016.

Device

Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI ...
  • Model / Serial
    Expression MRI Patient Monitoring System (Used to monitor vital signs of patients undergoing MRI procedures)Product Code: 865214 (In vivo Expression MRI Patient Monitoring System)Serial Numbers: US31204924, US31205148, US31205180, US42707074, US42707166, US42707375, US42707396ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA