Events

Device Recall 1500T9 Cardiac Ablation Generator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude Medical 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
    60996
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1032-2012
  • 사례 시작날짜
    2012-01-05
  • 사례 출판 날짜
    2012-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107008
  • 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
    Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • 원인
    Two st jude medical 1500t9 rf generator units were distributed to customers while still under fda review as part of a pma supplement to the approved pma applications.
  • 조치
    The notification letter was dated January 5th, 2012 and titled "Product Recall RF Generator 1500T9-CP". The letter informed customers that a St Jude Medical 1500T9-CP RF Generator unit had been distributed to them while currently under FDA review as part of a PMA supplement application. The letter requested that the use of the impacted generator be discontinued. Customers were requested to return the field action form and return the unit identified in the letter. The contact number provided in the letter is: 651-756-2000.

Device

Device Recall 1500T9 Cardiac Ablation Generator
  • 모델명 / 제조번호(시리얼번호)
    T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, including the states of Kansas and Maryland.
  • 제품 설명
    The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc
  • 제조사 주소
    St Jude Medical Inc, 177 E County Road B, Saint Paul MN 55117-1951
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA