Events

Rappel de Laser photocoagulator Easyret software version 1.03

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty 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-2017-RN-00507-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-21
  • 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-2017-RN-00507-1
  • 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 manufacturer quantel medical has become aware of an issue with the micropulse mode of the easyret laser (qm-pabx0017, serial number 155) in software version 1.03. if the validation key of the intermediate window for treatment lens and spot size selection is pressed twice when selecting the micropulse mode, a software bug leading to the delivery of an erroneous level of energy corresponding to a 100% duty cycle when in treatment session will be created. this issue could cause photocoagulation of the retina in patients.
  • Action
    Device Technologies Australia (DTA) is advising users to discontinue use of the MicroPulse mode on the device until the software update in version 1.04 has been completed by a DTA representative. This action has been closed-out on 15/03/2018.

Device

Laser photocoagulator Easyret software version 1.03
  • Modèle / numéro de série
    Laser photocoagulator Easyret software version 1.03Product Code: QM-PABX0017Serial Number: 155ARTG Number: 130657
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd