Events

Recall of Invivo Expression MRI Patient Monitoring System - Product 865214

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-00597-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00597-1
  • 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
    The device's labelling inaccurately indicates “endotracheal” as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.
  • Action
    Philips is advising end users that the FlexTEMP reusable temperature sensor cannot be in endotracheal site. Philips is working to correct this labelling issue and will contact customers with an update on its implementation plan. This action has been closed-out on 09/08/2016.

Device

Invivo Expression MRI Patient Monitoring System - Product 865214
  • Model / Serial
    Invivo Expression MRI Patient Monitoring System - Product 865214Units Affected - Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 - US42708744). Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this medical device correction.ARTG Number: 189095
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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