Events

OVATIO / PARADYM / PARADYM 2 / PARADYM RF / INTENSIA devices 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 Sorin Group Italia S.r.l. 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
    1075
  • 날짜
    2017-04-28
  • 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

OVATIO / PARADYM / PARADYM 2 / PARADYM RF / INTENSIA devices
  • 모델명 / 제조번호(시리얼번호)
    Model Number: Model number OVATIO family is constituted by the following models:  OVATIO VR 6250  OVATIO DR 6550  OVATIO CRT 6750 PARADYM ICD/CRT-D family is constituted by the following models: • PARADYM VR 8250 • PARADYM DR 8550 • PARADYM CRT-D 8750 • PARADYM SonR 8770 • PARADYM SonR TriV 8970 PARADYM 2 ICD/CRT-D family is constituted by the following models: • PARADYM 2 VR 8252 • PARADYM 2 DR 8552 • PARADYM 2 CRT-D 8752 • PARADYM 2 SonR CRT-D 8772 PARADYM RF ICD family is constituted by the following models: • PARADYM RF VR 9250 • PARADYM RF DR 9550 • PARADYM RF CRT-D 9750 • PARADYM RF SonR 9770 INTENSIA ICD family is constituted by the following models: • INTENSIA VR 124 • INTENSIA DR 154 • INTENSIA CRT-D 174 • INTENSIA SonR CRT-D 184 Serial Number: All distributed OVATIO / PARADYM/ PARADYM 2 /PARADYM RF/ INTENSIA devices, of which approximately 67,183 have been distributed as of December 31st, 2016.
  • 제품 설명
    Active implantable medical devices
  • Manufacturer
    Sorin Group Italia S.r.l.

Manufacturer

Sorin Group Italia S.r.l.