Events

Rappel de Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular Imaging SystemsBrightView, BrightView X / XCTCardio MDForteGemini TF/ GXl (6 slice) / TF Astonish/ 16 Power/ GXL / TF 64 w/ TOF PerformanceIngenuity, Ingenuity Core/ Core 128/ CT/ CT 728326/ Flex/ TF PET/CTPrecedenceBrilliance CT 16 Slice/ 64 Channel/ Big Bore Oncology/ iCT/ iCT - BETA TEST SYSTEM/ iCT SPMX 16 Slice

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-00297-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-01
  • 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-00297-1
  • 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
    Without preventative maintenance, and/or periodic battery replacement, ups devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. all lead/acid battery-based ups devices are susceptible to this issue. hazards involved as a result of ups devices failing include, but are not limited to:· chemical burn· thermal burn· eye, nose and/or throat irritation.
  • Action
    Customers are advised to review the material supplied with the customer letter and implement a UPS maintenance program at their facility. If users detect an unusual odour, heat, or see liquid in the area of the UPS, do not touch the UPS or any surrounding liquid. Follow institution’s procedures for potentially hazardous material. Be aware of all people in the vicinity of the potentially hazardous situation, including but not limited to patients, staff, and service personnel. Contact the service provider immediately. This action has been closed-out on 09/08/2016.

Device

Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular...
  • Modèle / numéro de série
    Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular Imaging SystemsBrightView, BrightView X / XCTCardio MDForteGemini TF/ GXl (6 slice) / TF Astonish/ 16 Power/ GXL / TF 64 w/ TOF PerformanceIngenuity, Ingenuity Core/ Core 128/ CT/ CT 728326/ Flex/ TF PET/CTPrecedenceBrilliance CT 16 Slice/ 64 Channel/ Big Bore Oncology/ iCT/ iCT - BETA TEST SYSTEM/ iCT SPMX 16 SliceARTG Numbers: 98868, 117440, 117642, 118077, 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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