Events

Rappel de Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01029-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-24
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01029-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Continuous use of the ip5 for more than 24 days, without power cycling, results in a graphical user interface (display screen) error, which causes the numeric data on the display to freeze and disables some menu keys. waveform data displayed and audible alarms are not impacted by this problem and continue to function properly. this could result in delay in treatment of the patient caused by the displayed numeric value not correlating with the patient's status.This is an update to the previous recall for product correction (tga ref.: rc-2014-rn-00349-1) which informed end users to ensure that the ip5 should be power cycled every 24 hours to prevent the above issue from occurring. now a permanent software solution is available.
  • Action
    A Philips representative will contact the customers and all affected devices will have a software update installed in order to address the problem. After the software update is installed, if the device is allowed to run for an extended period of time, the device will begin to notify users of the need to power cycle the device using various degrees of warning “restart required” prompts (dialog boxes). If the device is not power cycled when this time expires, the device will power down and sound a tone to inform users of the action. Until the software solution is implemented, users should ensure that the IP5 is power cycled once every day. This action has been closed-out on 5/08/2016.

Device

Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient mo...
  • Modèle / numéro de série
    Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring system)Product Code: 865471 Service Number 453564251511Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA