Events

Device Recall Symbia Radiation Therapy Pallet 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
    58918
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2980-2011
  • 사례 시작날짜
    2011-06-22
  • 사례 출판 날짜
    2011-08-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100609
  • 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
    Pallet for Radiation Computed Tomography (CT), Radiation Therapy - Product Code KPS
  • 원인
    There a potential patient safety issue when using the symbia radiation therapy pallet. when a patient is not iso-centered before starting a scan with the symbia t series systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.
  • 조치
    Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated June 06, 2011 to all affected customers. The letter informs customers of the potential safety issue if the patient is not iso-centered before starting a scan and a non-circular orbit is selected and provided recommendations including ensure the patient is iso-centered before starting a scan. If the patient cannot be positioned at the iso-center of the RTP, instructions were provided. The customers are asked to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter. For questions or assistance contact Siemens Medical Solutions USA, Inc. at (800) 888-7436 (USA).

Device

Device Recall Symbia Radiation Therapy Pallet
  • 모델명 / 제조번호(시리얼번호)
    material number 10412621, serial numbers 1023, 1045, 1052, 1067, 1073, 1076, 1083, 1110, 1116, 1118, 1136, 1137, 1141, 1146, 1154, 1155, 1167 and 1241
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide (USA) including the states of Florida and Texas; and the countries of Canada, China, Italy, Mexico, Poland, Portugal and Russia.
  • 제품 설명
    Symbia Radiation Therapy Pallet. || Siemens Medical Solutions USA, Inc. || An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA