Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Trumpf Medical Systems, Inc. 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 049 04 16 000
  • 사례 시작날짜
    2016-04-12
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9177
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The universal arm support enables precise positioning of the patient’s arm during surgical procedures. during our continuous monitoring and analysis of trumpf medical products installed in the field customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. the feedback describes the issue occurring while attempting to secure the position of the device. with this preventive field action trumpf medical proactively wants to ensure the safe intended use of the universal arm support. the product has not been involved with any reported injuries.

Device

Universal Arm Support
  • 모델명 / 제조번호(시리얼번호)
    Product Name: Universal Arm Support 450 Model Number: 1697630 up to serial number: 102441510 Product Name: Universal Arm Support 450 T Model Number: 1697635 up to serial number: 102472407 Product Name: Universal Arm Support 600 Model Number: 1697639 up to serial number: 102406761 Product Name: Universal Arm Support 600 T Model Number: 1697651 up to serial number: 102412823 Product Name: Universal Arm Support 450 U Model Number: 1697660 up to serial number: 102426024 Product Name: Universal Arm Support 450 U T Model Number: 1697662 up to serial number: 102452250
  • 제품 설명
    Arm Support
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA