Events

Recall of Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)

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-2014-RN-00829-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00829-1
  • 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
    When contact electrostatic discharge (esd) is applied to one of the four screws on the rear enclosure panel of the ip5, the wireless function of the ip5 radio could be interrupted. if this were to occur, there could be a loss of wireless communication between the ip5 and host monitoring system, the expression mri patient monitoring system or the expression mr200 mri patient monitoring system. this could potentially lead to a delay in treatment or diagnosis of the patient.
  • Action
    A Philips representative will contact affected customers to arrange for the addition of two ferrite clamps to a cable located inside the device to protect against an electrical pulse from ESD. Philips has advised that the IP5 can continue to be used and have provided work around instructions to reduce the risk of electrical pulse from ESD. This action has been closed-out on 1/06/2016.

Device

Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)
  • Model / Serial
    Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)Product Code: 865471 Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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