Events

Device Recall Siemens Mobilett Mira 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc 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
    63042
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2322-2012
  • 사례 시작날짜
    2012-08-21
  • 사례 출판 날짜
    2012-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112355
  • 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
    During regular product monitoring, siemens has become aware of a potential issue with the mobilett mira system. during normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. this may cause the system to continuously move. in response, siemens has issued update instruction xp038/12/s to r.
  • 조치
    Siemens initiated their correction of the MOBILETT Mira on August 21, 2012 by sending an "UPDATE INSTRUCTIONS XP038/12/S to all affected customers. The Instruction identifies the product, problem, and work steps for customers to follow. A XP038/12/S Completion Protocol letter was included for customers to complete and file with the instruction once the update is completed.

Device

Device Recall Siemens Mobilett Mira
  • 모델명 / 제조번호(시리얼번호)
    Model number 10273100 -- serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
  • 제품 설명
    Siemens Mobilett Mira. || Mobile X-Ray System.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA