Events

CARTO 3 EP Navigation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biosense Webster, 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
    75012
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2776-2016
  • 사례 시작날짜
    2016-08-15
  • 사례 출판 날짜
    2016-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149112
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • 원인
    Biosense webster, inc. is initiating a voluntary correction to re-install identified carto 3 systems that were moved and installed in china without testing and approval by biosense webster technical services, as described in the instructions for use (ifu).
  • 조치
    Biosense Webster sent a Customer Notification letter dated August 23, 2016, to all affected customers to inform them that Biosense Webster, Inc. recently became aware that some systems were improperly transported and installed at hospitals in China by Biosense Webster, Inc. Clinical Specialists. The letter informs the customers that according to the CARTO 3 System Instructions for Use (IFU), only the Biosense Webster, Inc. Technical Services team members are authorized to properly install the systems. Customers are informed that each impacted CARTO 3 System must be fully tested and approved by the Biosense Webster, Inc.Technical Services Team. The letter informs the customers of the actions to be taken. Actions Requested on Your Part: 1. Read this Medical Device Correction notification carefully. 2. If a CARTO¿ 3 System currently resides within your hospital, the system has been corrected, and you should ensure that you have received a Field Service Report that indicates the system is in order. For questions regarding this recall call 909-839-8500. 3. Review, complete, sign, and return the Acknowledgement Form in accordance with the instructions listed on the form. 4. In the future, if a CARTO¿ 3 System is installed in your facility, you should only conduct a clinical procedure after you have received a Field Safety Report dated after the installation of the device indicating that the system is in order. 5. Maintain awareness of this notice and pass this notice on to anyone in your facility that needs to be informed. Customers with any questions are instructed to contact their Biosense Webster, Inc. sales representative.

Device

CARTO 3 EP Navigation System
  • 모델명 / 제조번호(시리얼번호)
    V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528  V 4.3: 61053, 61054, 61059, 11701, 12664  V 2.3: 14218, 13208, 50203, 50531, 14718, 50573
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    International Distribution to China, Hong Kong and Brazil.
  • 제품 설명
    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. || The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • 제조사 주소
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA