Events

Recall of Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)

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-2017-RN-01171-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01171-1
  • 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 st-segments in a 12-lead ecg may become distorted and the st-value may be inaccurate when an affected monitor automatically activates ecg filtering in the event that a “ecg check cable” or “ecg noisy elec xx” inop condition is triggered and displayed. these inops are triggered when the monitor detects a low impedance between ecg lead wires and the cable shield in the lead set, which can be caused by mechanical damage or fluid ingress.Distortions on the st-segment and associated numerics can contribute to a misdiagnosis or misinterpretation, which can cause a delayed or an incorrect treatment.
  • Action
    Users are to complete and return the supplied acknowledgment form. Until the software is updated, users are to ensure that the “ECG Check Cable” or “ECG Noisy Elec xx” INOP is actioned following the instructions in the corresponding IFU. A Philips Healthcare representative will contact customers with affected devices to arrange a software update to correct the issue.

Device

Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (...
  • Model / Serial
    Philips IntelliVue Patient Monitors ECG 12-lead option #C12(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)Affected Products:IntelliVue Multi Measurement ServerProduct Number: M3001AIntelliVue Multi Measurement Server SLCPProduct Number: M3001ALIntelliVue Multi Measurement Server X2Product Number: M3002AIntelliVue MP2Product Number: M8102AIntelliVue MP5Product Number: M8105AARTG Numbers: 118076 and 213953
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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