Events

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 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-00297-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00297-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA