Events

Device Recall da Vinci Dual Camera Controller 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Intuitive Surgical, 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
    65590
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1688-2013
  • 사례 시작날짜
    2013-06-08
  • 사례 출판 날짜
    2013-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119693
  • 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,surgical,computer controlled instrument - Product Code NAY
  • 원인
    Factory testing on da vinci si surgical systems may not be in compliance with ul standards as one of the testing devices was found to be working incorrectly.
  • 조치
    Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3. For questions regarding this recall call 408-523-2244.

Device

Device Recall da Vinci Dual Camera Controller
  • 모델명 / 제조번호(시리얼번호)
    Part number 372019-01: Serial numbers:  323943 323895 323882 323945 323994 323804 323979 323987 324042 324086.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
  • 제품 설명
    da Vinci Dual Camera Controller, model number DC3000; || Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. || Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • 제조사 주소
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • 제조사 모회사 (2017)
    Intuitive Surgical Inc
  • Source
    USFDA