Events

Device Recall MobileDaRt Evolution 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Shimadzu Medical Systems 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
    72683
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0451-2016
  • 사례 시작날짜
    2015-11-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141974
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, x-ray, mobile - Product Code IZL
  • 원인
    The firm is recalling the shimadzu mobile x-ray system because an image may not transfer to image server properly.
  • 조치
    Shimadzu sent an Urgent Voluntary Medical Device Recall Notice dated November 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to customers to inform them that Shimadzu is recalling the Mobile X-ray system MobileDaRt Evolution because of reports that an image was not transferred to image server properly. Customers with questions are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

Device

Device Recall MobileDaRt Evolution
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 41DBBB534001 41DBBB534004 41DBBB534002 41DBBB534005 41DBBB534006 41DBBB536001 41DBBB536007 41DBBB536008 41DBBB536009 41DBBB536010 41DBBB539001 41DBBB539002 41DBBB539003 41DBBB539004 41DBBB53A001 M1DBBB547001 M1DBBB547002 M1DBBB547003 M1DBBB547004 M1DBBB547005 M1DBBB547006 M1DBBB547007 M1DBBB548001 M1DBBB548002  41DBBA136010 41DBBA136014 41DBBA145008 41DBBA145009 41DBBA145016 41DBBA141006 41DBBA147004 41DBBA149021 41DBBA149022 41DBBA132003 41DBBA142001 41DBBA14A004 41DBBA132001 41DBBA132010 41DBBA141012 41DBBA142012 41DBBA147017 41DBBA147028 41DBBA146015 41DBBA146017 41DBBA142004 41DBBA142014 41DBBA148002 41DBBA131018 41DBBA131020 41DBBA136006 41DBBA136011 41DBBA141013 41DBBA14A010 41DBBA142019 41DBBA142020 41DBBA149005 41DBBA145024 41DBBA143002 41DBBA141009 41DBBA136003 41DBBA136004 41DBBA132002 41DBBA146021 41DBBA146028 41DBBA14A007 41DBBA141001 41DBBA142015 41DBBA146002 41DBBA147008 41DBBA14A015 41DBBA132012 41DBBA132016 41DBBA131004 41DBBA136013 41DBBA142009 41DBBA137001 41DBBA146019 41DBBA14A022 41DBBA147013 41DBBA146006 41DBBA146014 41DBBA146037 41DBBA146044 41DBBA146045 41DBBA147006 41DBBA143005 41DBBA147007 41DBBA145005 41DBBA14B005 41DBBA132015 41DBBA131016 41DBBA146043 41DBBA131001 41DBBA145015 41DBBA145018 41DBBA131011 41DBBA147015 41DBBA14A014 41DBBA14A017 41DBBA137005 41DBBA132017 41DBBA147019 41DBBA14A023 41DBBA147016 41DBBA136002 41DBBA146039 41DBBA145014 41DBBA132006 41DBBA146009 41DBBA132011 41DBBA144004 41DBBA14A024 41DBBA142017 41DBBA14A002 41DBBA14A012 41DBBA145007 41DBBA149002 41DBBA147021 41DBBA136007 41DBBA136008 41DBBA142002 41DBBA142010 41DBBA145026 41DBBA131005 41DBBA131007 41DBBA149006 41DBBA14A005 41DBBA14A013 41DBBA149017 41DBBA149010 41DBBA149011 41DBBA14B004 41DBBA147018 41DBBA14C001 41DBBA14C004 41DBBA149008 41DBBA148001 41DBBA149003 41DBBA149007 41DBBA149004 41DBBA145025 41DBBA145029 41DBBA145031 41DBBA145033 41DBBA14B002 41DBBA133005 41DBBA131003 41DBBA133009 41DBBA145038 41DBBA147020 41DBBA142011 41DBBA145003 41DBBA145011 41DBBA146007 41DBBA141011 41DBBA145004 41DBBA14A009 41DBBA145017 41DBBA145032 41DBBA146018 41DBBA146042 41DBBA146005 41DBBA149018 41DBBA145036 41DBBA145019 41DBBA145022 41DBBA145006 41DBBA145020 41DBBA145021 41DBBA14C002 41DBBA133001 41DBBA133002 41DBBA133011 41DBBA145028 41DBBA14A021 41DBBA146026 41DBBA146027 41DBBA144001 41DBBA144003 41DBBA141002 41DBBA141004 41DBBA144006 41DBBA145001 41DBBA147023 41DBBA147024 41DBBA147030 41DBBA132004 41DBBA132008 41DBBA136012 41DBBA14A001 41DBBA146013 41DBBA147001 41DBBA149014 41DBBA146004 41DBBA146008 41DBBA146016 41DBBA146040 41DBBA147025 41DBBA149001 41DBBA136005 41DBBA145012 41DBBA137002 41DBBA137003 41DBBA141003 41DBBA147002 41DBBA147003 41DBBA147005 41DBBA131013 41DBBA149015 41DBBA144007 41DBBA145002 41DBBA147027 41DBBA146020 41DBBA146033 41DBBA133010 41DBBA149013 41DBBA149012 41DBBA132009 41DBBA131015 41DBBA132018 41DBBA149019 41DBBA145013 41DBBA14A003 41DBBA14A008 41DBBA146022 41DBBA142007 41DBBA145010 41DBBA144002 41DBBA144005 41DBBA145034 41DBBA145035 41DBBA132013 41DBBA133004 41DBBA133012 41DBBA147031 41DBBA149016 41DBBA14A006 41DBBA149009 41DBBA142018 41DBBA147022 41DBBA14A016 41DBBA132007 41DBBA146003 41DBBA133007 41DBBA145027 41DBBA132005 41DBBA141005 41DBBA141010 41DBBA137004 41DBBA143001 41DBBA143003 41DBBA143004 41DBBA141016 41DBBA141017 41DBBA142003 41DBBA142005 41DBBA142006 41DBBA142013 41DBBA141008 41DBBA142008 41DBBA142016 41DBBA145030 41DBBA146023 41DBBA146024 41DBBA146025 41DBBA146030 41DBBA146031 41DBBA146032 41DBBA146034 41DBBA146035 41DBBA146036 41DBBA146038 41DBBA145023 41DBBA147026 41DBBA146010 41DBBA141007 41DBBA146012 41DBBA131009 41DBBA131010 41DBBA131006 41DBBA131002 41DBBA131008 41DBBA131012 41DBBA131014 41DBBA131017 41DBBA133006 41DBBA133008 41DBBA145037 41DBBA146029 41DBBA131019 41DBBA132014 41DBBA133003 41DBBA133013 41DBBA136001 41DBBA136009 41DBBA136015 41DBBA14A025    M1DBBB542001 M1DBBB542002 M1DBBB543001 M1DBBB546003
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution and Internationally to Canada
  • 제품 설명
    Mobile X-ray system MobileDaRt Evolution/FDR Go Software || The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • 제조사 주소
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • 제조사 모회사 (2017)
    Shimadzu Corp.
  • Source
    USFDA