Events

Rappel de SONY LMD-1951MD MONITORS

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

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-00032-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-16
  • 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-00032-1
  • 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
    In some situations, a lmd-1951md medical monitor has either not turned on or has lost the image during clinical use. sony's investigation indicates that the issue is the result of a potential disconnection of the internal power supply caused by a failure of a power board integrated circuit. this problem is caused by a non-conformity in the circuit board resulting in a short circuit with over-current and damage to the circuitry and concomitant loss of image. the failure does not occur when an ac adapter (ac-110md) is used with the monitor.
  • Action
    Sony is replacing the power board of all affected units. In the interim, end users are advised to only use the AC adapter to avoid the issue occurring. This action has been closed-out on 18/07/2016.

Device

SONY LMD-1951MD MONITORS

Manufacturer

Sony Australia Limited
  • Société-mère du fabricant (2017)
    Sony Corp.
  • Source
    DHTGA