Events

Rappel de OmniDiagnost-Eleva and OmniDiagnost-Classic

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-2018-RN-00595-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-18
  • 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-2018-RN-00595-1
  • 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
    Philips has received reported instances in which the table of the omnidiagnost system (od-eleva) suddenly started to rotate from 0 to 90 degrees (table arm down) with high speed. the cause of this unexpected rotation movement is related to an issue with the fixation of the upper and lower tilt actuator. this rotating movement cannot be stopped by the user.If the system rotates uncontrolled, there is a risk of injury for the patient on the table. a rotating table also might hit a user or bystander standing near the system.
  • Action
    Philips is advising they will be in contact with users to replace affected components on the upper and lower tilt actuator in the impacted systems. It is expected that this action will commence July 2018. In the interim, users should monitor the tables for any of the following, stop use of, and contact Philips immediately if they occur: - the table height or tilt movement is not working; - a cracking or snapping sound is heard during system operation; - a blockade is experienced in the table height or tilt movement during system movements; - the system is having an unexpected collision or the system had an unexpected collision in the past 2 months; - a CPR stand that obstructed the system when in use,; or - any (other) unusual system behaviour beyond the normal use of the system.

Device

OmniDiagnost-Eleva and OmniDiagnost-Classic
  • Modèle / numéro de série
    OmniDiagnost-Eleva and OmniDiagnost-Classic System Codes: 708026, 708027, 708028, 20859, 708023, 708024, 708025ARTG Number: 98560(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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