Events

Device Recall AccuSeed DS Digital Stepper 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Computerized 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
    36665
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0221-2007
  • 사례 시작날짜
    2006-11-09
  • 사례 출판 날짜
    2006-11-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49115
  • 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
    radioactive seed placement system - Product Code ITX
  • 원인
    The in/out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
  • 조치
    The recalling firm issued letters dated 11/9/06 via regular mail. The letter informs the customer of the problem and includes an advisory notice instructing them to perform a test prior to each use. If the system does not function correctly, it can still be used safely in a manual mode until it can be returned for repair. A questionnaire was enclosed that will facilitate the firm in prioritizing repairs and retrofits. After the questionnaire is reviewed, the firm will contact the customer for further information regarding their facilities use of the device. This letter was also issued to the CMS customer support departments in Japan, China, and Europe, who will notify the foreign customers and prioritize their returns for repair.

Device

Device Recall AccuSeed DS Digital Stepper
  • 모델명 / 제조번호(시리얼번호)
    All Model #DS300 steppers
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil.
  • 제품 설명
    AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • 제조사 주소
    Computerized Medical Systems Inc, 1145 Corporate Lake Dr Ste 100, Saint Louis MO 63132-1716
  • Source
    USFDA