Events

Recall of Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96

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-2016-RN-00090-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00090-1
  • 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 st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the following host monitor configuration:st analysis: “off” ste: “on“ste alarms: “on”the problem only occurs if either of the affected philips intellivue measurement modules are used with philips intellivue patient monitors with hexad option #c54 (also bundled in options h11, h41, h42, cp2), or if an affected x2 measurement module is used in standalone mode (i.E., not connected to another monitor).There is potential for delay in diagnosis due to the monitor not alarming for st elevation on the chest leads.
  • Action
    Philips Healthcare is advising users to ensure the ST Analysis is switched to ON when using STE measurement. A software upgrade will be installed as a permanent correction.

Device

Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versio...
  • Model / Serial
    Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96Affected Philips IntelliVue Measurement Modules:Model Number: X1Product Number: M3001A Software Revision: K.21.54 or L.00.96Model Number: X2Product Number: M3002A Software Revision: K.21.54 or L.00.96 ARTG Number: 94238
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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