Events

Maestro Cardiac Ablation System 에 대한 현장 안전성 서한

Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems에 따르면, 해당 현장 안전성 서한 는 Czechia 에서 Boston Scientific Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 ID
    1604
  • 날짜
    2018-06-25
  • 사례 국가
    Czechia
  • 사례 출처
    MHSIDCCCDMIS
  • 사례 출처 URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • 비고 / 경고
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • 데이터 추가 비고

Device

Maestro Cardiac Ablation System
  • 모델명 / 제조번호(시리얼번호)
    Model Number: Maestro 4000 Footswitch: M004218500- Maestro 4000 Footswitch M00421850D0- Maestro 4000 Footswitch, Demo M00421850H0- Maestro 4000 Footswitch, Hospital Owned M00421850R0- Maestro 4000 Footswitch, Repaired M00421850Z0- Maestro 4000 Footswitch, Zero Cost Maestro Pump to Generator Cable: M004315000- Cable OI Pump to OI Maestro Maestro 4000 Controller: M00440000- Maestro 4000 Controller M0044000D0- Maestro 4000 Controller, Demo M0044000H0- Maestro 4000 Controller, Hospital Owned M0044000R0- Maestro 4000 Controller, Repaired M0044000Z0- Maestro 4000 Controller, Zero Cost
  • 제품 설명
    Electromechanical medical devices
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHSIDCCCDMIS