syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd 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
    RC-2015-RN-00443-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-28
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    While configured for the batching of orders, when an order transaction is received from a his interface, it is temporarily read into the system while waiting for the next transaction to come across the interface. if the next transaction is another procedure for the same patient, it would be "batched" with the first order until a transaction that is not an order for the "batched" patient is received or the maximum wait time of 10 seconds is exceeded. at this point, all the order(s) would be processed.If the system receives a shutdown request to restart the interface process while an order is within this 10 second "batching" window, the order may be lost with no indication to the user. this condition can happen when a user manually attempts to restart the interface process or when all of the application processes are restarted during the day-end processing sequence.
  • 조치
    The issue can be avoided by not using the Order Batching feature. If the Order Batching feature is used. Users are recommended to configure the day-end processing to take place at the time with the anticipated lowest number of order transactions until the issue is solved in the software.For new upgrades or new installations, the issue will be solved in the syngo Workflow SLR software version VB20A_HF01 which is planned to be released in 02/2015. For existing VA31, VA32, VB10, and VB20A sites, the issue will be resolved following Safety Update Instruction SY038/15/S which is planned to be released in 02/2015. This action has been closed-out on 31/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information system) Catalogue number: 10558586ARTG number: 142663
  • Manufacturer

Manufacturer