Events

Device Recall Siemens syngo Imaging XS 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
    61071
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1064-2012
  • 사례 시작날짜
    2012-01-26
  • 사례 출판 날짜
    2012-02-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107231
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    In september 2011 firm issued two customer safety advisory notices for syngo imaging xs. firm became aware of an unintended behavior when using syngo imaging xs, version va70a and va70b with client/server installations. loading additional images/series from the patient browser using the thumbnails may cause unintended deletion of images/series. in response, firm issued a customer safety advisor.
  • 조치
    Siemens Medical issued an "UPDATE INSTRUCTIONS SY055/11/S/UPDATE PACKAGE VA70B_0211" to all affected customers. The package described the product, problem, and instructions for customers to follow.

Device

Device Recall Siemens syngo Imaging XS
  • 모델명 / 제조번호(시리얼번호)
    Model number 10496279 -- serial numbers 1344, 1744, 1187, 2981, 1361, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3061, 2323, 2254, 1088, 1089, 2194, 2195, 1213, 1214, 1188, 1189, 3086, 2626, 1828, 1624, 1625, 2878, 2365, 2366, 3087, 3088, 3089, 2500, 2971, 1424, 1425, 3093, 2890, 1371, 1372, 3062, 2267, 2268, 2269, 1856, 1857, 2695, 2696, 3010, 1373, 1374, 1375, 1376, 1377, 1713, 1712, 2408, 2409, 2559, 2560, 2561, 2562, 1735, 1668, 2098, 1190, 1418, 2069, 2698, 2769, 1884, 1381, 1382, 1378, 1379, 1380, 1165, 2310, 2311, 2312, 2448, 2449, 2450, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2324, 1940, 1395, 2901, 2897, 2898, 2899, 2900, 2934, 3017, 2144, 2145, 2146, 2147, 2148, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2200, 2201, 1383, 3050, and 3085.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the states of CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
  • 제품 설명
    Siemens syngo Imaging XS. || Radiological image processing 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