Events

Device Recall TruVidia Wireless Camera System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Trumpf Medical Systems, 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
    79336
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0824-2018
  • 사례 시작날짜
    2017-12-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162052
  • 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
    Camera, television, surgical, without audio - Product Code FWB
  • 원인
    The radiated emission from the truvidia" wireless receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
  • 조치
    Trumpf Medical Systems sent an Urgent Medical Device Correction letter dated December 15, 2017. Instructions include to complete and return the Confirmation of Receipt, arrange for the Trumpf Medical Engineer or an authorized Service Engineer to upgrade the affected device, and ensure that all users of the device are aware of the recall. For further questions, please call (843) 329-0543

Device

Device Recall TruVidia Wireless Camera System
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 1940747, All serial numbers: 102584474, 102584475, 102584477, 102584478, 102805330, 102813656, 102813657, 102813658, 102813659, 102813660, 102813661, 102813662, 102860647, 102860652, 102863706, 102863707, 102867783, 102867784, 102925734, 102925735, 102925736, 102925737, 102925738, 102925739, 102925740, 102925741, 102925742, 102925743, 102928703, 102932185, 102932186, 102932187, 102932188, 102932189, 102932203, 102932204, 102932205, 102932206, 102932207, 102932208, 102932209, 102932210, 102932211, 102932212, 102932217, 102932218, 102932219, 102932220, 102932221, 102932223, 102934525, 102934526, 102934527, 102934528, 102934529, 102936117, 102939484, 102940382, 102940383, 102940384, 102940386, 102940387, 102940388, 102940389, 102940390, 102940391, 102940408, 102940409, 102940410, 102961390, 102961391, 102961392, 102961393, 102961394, 102961395, 102961396, 102961397, 102961398, 102961399, 102961400, 102961401, 102975336, 102986494, 102986495, 102988480, 102989096, 102989607, 102989608, 102989615, 102990285, 102990286, 102994502, 102994503, 102994504, 102994505, 102994506, 102994525, 102994526, 102994529, 102994530, 102996306, 103005879, 103005880, 103005889, 103005890, 103005891, 103005892, 103005893, 103006636, 103010023, 103010759, 103010760, 103010761, 103010762, 103010763, 103012786, 103012787, 103013644, 103017040, 103017041, 103019900, 103020713, 103022348, 103022349, 103022350, 103022351, 103022352, 103022794, 103024049, 103024050, 103030284, 103031623, 103034106, 103034109, 103038842, 103038843, 103038844, 103038845, 103038846, 103038847, 103038848, 103038849, 103038850, 103038853, 103038854, 103038855, 103038856, 103038857, 103038858, 103038859, 103038860, 103038861, 103038862, 103038863, 103038864, 103038865, 103038866, 103039468, 103042319, 103042320, 103042321, 103042322, 103042925, 103042926, 103046119, 103046120, 103046121, 103046122, 103046123, 103046124, 103046125, 103046126, 103046127, 103046128, 103046129, 103046130, 103048248, 103065061, 103070795, 103070796, 103070797, 103070798, 103079001, 103079053, 103087365, 103087366, 103087367, 103087368, 103087369, 103087370, 103087371, 103090135, 103090136, 103090137, 103091507, 103091508, 103091509, 103091510, 103091511, 103095664, 103101676, 103101826, 103101864, 103101886, 103103841, 103103842, 103103843, 103103844, 103103845, 103104556, 103113059, 103117961, 103118986, 103118987, 103118988, 103118989, 103118990, 103118991, 103118992, 103118993, 103118994, 103118995, 103123759, 103133224, 103134656, 103138822, 103143214, 103149993, 103164298, 103168053, 103168341, 103168431, 103176559, 103176571, 103176574, 103191728, 103191729, 103194419, 103214005, 103214022.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of : GA, IL, IN, PA, SC, TX, UT, VA. and to the countries of : Austria, Australia, Bangladesh, Belgium, France, Switzerland, Czech Republic, Germany, Denmark, Spain, United Arab Emirates, United Kingdom, Ireland, Italy, Kuwait, Lithuania, Poland, Portugal, Romania, Sweden, Slovenia, Thailand, Turkey.
  • 제품 설명
    Camera System, Television, Surgical without audio || Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • 제조사 주소
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA