Events

Device Recall Siemens brand 550 TxT Patient Treatment Table 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
    55577
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2023-2011
  • 사례 시작날짜
    2010-03-31
  • 사례 출판 날짜
    2011-04-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91174
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • 원인
    Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.
  • 조치
    Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of the table by the integration of additional relays. As soon as the "move enable" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table. Further questions regarding this recall please call (925) 246-8407

Device

Device Recall Siemens brand 550 TxT Patient Treatment Table
  • 모델명 / 제조번호(시리얼번호)
    All units of Listing Number: R864406
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.
  • 제품 설명
    Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478. || The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA