Events

Rappel de Philips HeartStart XL+ Defibrillator/Monitor

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-2015-RN-00588-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • 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-2015-RN-00588-1
  • 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
    The following xl+ software and hardware issues have been identified:software:the xl+ may fail to complete the power on sequence and continuously reboot. the xl+ may either fail to power up or may shut down unexpectedly. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. the xl+ may fail to generate verbal prompts in aed mode. hardware:the xl+ may have been manufactured with a speaker that may fail. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. the xl+ exceeds the allowable radiated emissions level for class b cispr11. the xl+ ecg signal from leads could be lost and unrecoverable. the xl+ spo2 signal may lose communication and cause the device to reboot. the xl+ battery detection system may be disrupted and cause a false low battery alarm.
  • Action
    A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software and hardware upgrades. In the interim, users can continue to use XL+ prior to receiving the software and hardware upgrades; however they should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits any of these issues.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Modèle / numéro de série
    Philips HeartStart XL+ Defibrillator/Monitor Units Affected: XL+ units with a serial number within the following ranges:USO1100100 to USD1101095US11201096 to USD1203968US11303969 to USD1309471US11409472 to US61414022ARTG Number: 95661
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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