Events

Pinnacle3 Software Version 10.0 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems, 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
    71117
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1643-2015
  • 사례 시작날짜
    2015-04-23
  • 사례 출판 날짜
    2015-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136154
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • 원인
    A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the philips pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. specifically, the dose engine is being passed the wrong snout position. the snout position is used to determine the penumbra of the beam which includes the calculation of the source si.
  • 조치
    Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (Contact Philips Customer Care Solutions Center at 1-800-722-9377).

Device

Pinnacle3 Software Version 10.0
  • 모델명 / 제조번호(시리얼번호)
    "System Code S/N"  1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of MO, FL, OH
  • 제품 설명
    Pinnacle3 Software Version 10.0, Model 459800200841. || Product Usage: || The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • 제조사 주소
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA