Events

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
    68107
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1622-2014
  • 사례 시작날짜
    2014-04-03
  • 사례 출판 날짜
    2014-05-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126950
  • 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
    A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.
  • 조치
    Siemens sent a Customer Safety Advisory Notice dated April 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our service organization already checked all syngo Imaging sites and did not find any other occurrence of the wrongly configured link. Additionally our service organization will include the check for such wrongly configured links into the existing proactive site monitoring procedures. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please include this safety advisory notice in your operator's manual. In the interests of safety, we ask that you perform the above preventive measures and inform all affected personnel immediately. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (610) 219-6300. .

Device

syngo Imaging XS
  • 모델명 / 제조번호(시리얼번호)
    material number: 10014063, with serial numbers: 1334 1065 1351 1491 1417 1269 1076 1043 1429 1353 1392 1258 1398 1445 1496 1279 1116 1090 1229 1080 1005 1081 1310 1246 1226 1057 1379 1396 1084 1322 1107 1453 1124 1343 1198 1432 1058 1247 1278 1082 1055 1049 1329 1203 1490 1083 1316 1395 1053 1079 1387 1448 1218 1451 1389 1386 1064 1500 1436 1074 1443 1210 1408 1427
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    syngo Imaging XS || Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
  • 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