Events

Recall of IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X

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-2018-RN-00494-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00494-1
  • 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
    Philips has identified that five warning statements are missing from the instructions for use (ifu) for intellivue mx40 ifu software revisions b.05, b.06 and b.06.5x. if users are unaware of the hazards or limitations described in the missing warning statements, they may not properly assess or provide appropriate treatment to a patient being monitored using an intellivue mx40.These ifus are missing warning statements related to monitoring of patients with pacemakers and the interpretation of qt/qtc measurements that were present in earlier revisions of the ifu. a “warning” alerts users to a potential serious outcome, adverse event or safety hazard. failure to observe a warning may result in death or serious injury to a user or patient.To date, no patient harm has been reported as a result of this issue.
  • Action
    Phillips will contact affected customers to provide a copy of an Instructions For Use (IFU) Errata. Customers are requested to attach the Errata Sheet to the first page of Chapter 6 of the IFU.

Device

IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X

Manufacturer

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