Events

Pinnacle3 Radiation Therapy Planning System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland), 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
    63430
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0206-2013
  • 사례 시작날짜
    2012-10-05
  • 사례 출판 날짜
    2012-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113761
  • 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, nuclear magnetic resonance imaging - Product Code IYE
  • 원인
    Philips medical systems cleveland), inc. is recalling pinnacle3 virtual client connection software version 3.1 due to an improper release and subsequent distribution.
  • 조치
    The firm, Philips Healthcare, sent a "Customer Information Letter" dated 2012 Oct 05. The letter listed the affected products, problem description, how to identify affected products, advise on actions by customer / user, actions planned by Philips and further information and support. The letter stated that no action is needed on the part of the customer. The field service engineer will be scheduling a site visit to complete the replacement. Philips Healthcare will be delivering the correct VCC kit. For customers in North America if you need any further information or support concerning this issue, please contact our Customer Care Solutions Center at 1-800-722-9377. Select option 5 for "All Imaging Systems". Enter your site ID # (If you do not have a site ID#, simply pause for a moment.). Select option 5 for "Nuclear Medicine" and finally select option 3 for "Pinnacle" support.

Device

Pinnacle3 Radiation Therapy Planning System
  • 모델명 / 제조번호(시리얼번호)
    Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: ME, MI, NY, and WI.
  • 제품 설명
    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. || Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
  • Manufacturer
    Philips Medical Systems (Cleveland), Inc.

Manufacturer

Philips Medical Systems (Cleveland), Inc.
  • 제조사 주소
    Philips Medical Systems (Cleveland), Inc., 5520 Nobel Dr Ste 125, Fitchburg WI 53711-4948
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA