Events

INTRABEAM Balloon Applicator Set; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carl Zeiss Meditec, 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
    63596
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0406-2013
  • 사례 시작날짜
    2012-10-25
  • 사례 출판 날짜
    2012-11-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114297
  • 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, therapeutic, x-ray - Product Code JAD
  • 원인
    A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
  • 조치
    Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.

Device

INTRABEAM Balloon Applicator Set;
  • 모델명 / 제조번호(시리얼번호)
    Part number 304534-7500-002; lot number 540960.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including IL and MD
  • 제품 설명
    INTRABEAM Balloon Applicator Set; || 4.0 cm, || Carl Zeiss Meditec AG, Oberkochen, Germany || INTRABEAM System is intended for radiation therapy treatments.
  • Manufacturer
    Carl Zeiss Meditec, Inc.

Manufacturer

Carl Zeiss Meditec, Inc.
  • 제조사 주소
    Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin CA 94568-7562
  • 제조사 모회사 (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA