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Rappel de Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007
Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ausmedic 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
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ID de l'événement
RC-2013-RN-00453-1
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Classe de risque de l'événement
Class III
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Date de mise en oeuvre de l'événement
2013-05-15
- Pays de l'événement
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Source de l'événement
DHTGA
- URL de la source de l'événement
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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
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Cause
Instances of frame failures have been identified where considerable heavy usage of the wheelchair has instigated a fracture in the aluminium tubing that supports the rear drive motors.
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Action
An upgrade kit has been supplied and fitted by a service engineer to reduce the potential for frame fracture occurring. For more details, please see http://www.tga.gov.au/safety/alerts-device-viper-wheelchairs-131003.htm .
Device
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Modèle / numéro de série
Viper & Viper Plus PowerchairsManufactured between July 2006 and July 2007This recall action was conducted prior to approval of the recall strategy by the Therapeutic Goods Administration.
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
DHTGA