Events

Retiro De Equipo (Recall) 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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00297-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-01
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00297-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA