Events

Device Recall Siemens syngo.plaza with software version VA20B_HF04 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
    61141
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1127-2012
  • 사례 시작날짜
    2012-01-20
  • 사례 출판 날짜
    2012-02-29
  • 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=107379
  • 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
    There is a potential malfunction when using syngo.Plaza va20b_hf04 with usb dongle and archive license. in syngo.Plaza va20b_hf04, there is a scenario where data in short-term storage (sts) could reaming unprotected and not archived. this can happen when an archive server with a usb dongle-based license is enabled with auto archiving. if the disk fill level is reached which triggers auto deleti.
  • 조치
    Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use.

Device

Device Recall Siemens syngo.plaza with software version VA20B_HF04
  • 모델명 / 제조번호(시리얼번호)
    Model number 10592457 - serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.
  • 제품 설명
    Siemens syngo.plaza with software version VA20B_HF04 || Product Usage: || 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