Events

SOMATOM Sensation 16 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
    30173
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0158-05
  • 사례 출판 날짜
    2004-11-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-09-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35313
  • 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, Tomography, Computed - Product Code JAK
  • 원인
    Calcium scoring feature on this devices is not closing properly after patient's exams.
  • 조치
    The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.

Device

SOMATOM Sensation 16
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 50008, 50013, 50014, 50022, 50025, 50026, 50027, 50029, 50034, 50036, 50037, 50040, 50042, 50044, 50048, 50050, 50054, 50058, 50062, 50066, 50073, 50075, 50079, 50081, 50085, 50086, 50089, 50093, 50096, 50097, 50100, 50105, 50106, 50110, 50113, 50123, 50124, 50131, 50134, 50138, 50139, 50141, 50142, 50146, 50152, 50154, 50156, 50158, 50162, 50165, 50166, 50168, 50174, 50175, 50178, 50181, 50183, 50186, 50190, 50192, 50193, 50194, 50202, 50203, 50205, 50212, 50219, 50222, 50224, 50226, 50234, 50238, 50245, 50249, 50250, 50255, 50258, 50262, 50263, 50266, 50273, 50274, 50278, 50283, 50285, 50288, 50293, 50300, 50308, 50310, 50316, 50317, 50325, 50327, 50332, 50334, 50340, 50343, 50351, 50356, 50365, 50374, 50379, 50380, 50391, 50392, 50394, 50394, 50396, 50409, 50412, 50416, 50421, 50429, 50433, 50435, 50452, 50454, 50455, 50458, 50459, 50461, 50462, 50465, 50466, 50467, 50471, 50472, 50473, 50479, 50482, 50483, 50488, 50490, 50491, 50494, 50497, 50501, 50512, 50525, 50530, 50534, 50535, 50540, 50543, 50549, 50550, 50555, 50556, 50557, 50560, 50561, 50564, 50568, 50570, 50573, 50575, 50576, 50577, 50579, 50580, 50582, 50585, 50588, 50590, 50591, 50595, 50597, 50600, 50609, 50610, 50611, 50615, 50621, 50622, 50626, 50627, 50628, 50631, 50632, 50636, 50639, 50640, 50643, 50644, 50545, 50650, 50651, 50653, 50665, 50668, 50669, 50672, 50674, 50682, 50683, 50685, 50686, and 50999.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to medical facilities nationwide and government account in IL.
  • 제품 설명
    SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model Number 73 93 114
  • 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 19355-1406
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA