iLab Ultrasound Imaging System

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    VNSAWH

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  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Ultrasonics
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Boston Scientific ILab Ultrasound Imaging System (FFR Link), Boston Scientific Corporation
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
  • 제품 설명
    iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    UPNs: H74900036130, H749FG000940, H749ILAB120INS0, H749ILAB120INSR0, H749ILAB220INS0, H749240INS0, M004EPIL120INS0. Serial numbers 0000004082, 0000004385, 0000004386, 0000004387, 0000004388, 0000004389, 0000004390, 0000004391, 0000004392, 0000004393, 0000004396, 0000004397, 0000004398, 0000004399, 0000004416, 0000004417, 0000004418, 0000004419, 0000004420, 0000004421, 0000004422, 0000004423, 0000004424, 0000004425, 0000004426, 0000004427, 0000004428, 0000004429, 0000004430, 0000004431, 0000004432, 0000004433, 0000004434, 0000004435, 0000004436, 0000004439, 0000004441, 0000004442, 0000004443, 0000004444, 0000004445, 0000004446, 0000004447, 0000004448, 0000004453, 0000004454, 0000004455, 0000004456, 0000004468, 0000004469, 0000004472, 0000004473, 0000004480, 0000004487, 0000004488, 0000004489, 0000004490, 0000004491, 0000004494, 0000004495, 0000004496, 0000004497, 0000004498, 0000004505, 0000004506, 0000004507, 0000004512, 0000004513, 0000004514, 0000004515, 0000004516, 0000004520, 0000004521, 0000004522, 0000004523, 0000004524, 0000004525, 0000004526, 0000004529, 0000004538, 0000004539, 0000004548, 0000004549, 0000004550, 0000004551, 0000004556, 0000004557, 0000004558, 0000004559, 0000004564, 0000004565, 0000004566, 0000004567, 0000004572, 0000004573, 0000004574, 0000004575, 0000004580, 0000004581, 0000004582, 0000004583, 0000004584, 0000004585, 0000004586, 0000004587, 0000004610, 0000004702, 0000004703, 0000004704, 0000004705, 0000004717, 0000004718, 0000004719, 0000004720, 0000004726, 0000004728, 0000004729, 0000004730, 0000004731, 0000004732, 0000004737, 0000004738, 0000004751, 0000035228, 0000035229, 0000035390, 0000035391, 0000036314, 0000094718, 0009430893, 0009503458, 0009543381, 0009565345, 0009902558, 0009602559, 0009626567, 0009640091, 0009828054, 0009828055, 0009828344, 0011008866.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.
  • 제품 설명
    iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    see list | see list
  • 제품 설명
    MD: Ultrasound imaging system, cardiovascular
  • Manufacturer
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