Events

Device Recall daVinci Surgical System Model IS1200, A4.3 SW level 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
    38069
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1244-2007
  • 사례 시작날짜
    2007-05-03
  • 사례 출판 날짜
    2007-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52892
  • 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
    Endoscopic Instrument Control System - Product Code NAY
  • 원인
    Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. in addition, there is an unrelated addendum to the user manual to clarify an icon not described in the previous user manual.
  • 조치
    As of 9/7/2007, Intuitive Field Service Engineers have performed the upgrade via service visit on 292 of 293 U.S. systems listed on the affected sites list. A notification letter that the upgrade has been performed was left with each site after the upgrade has been completed. The firm's distributors received advance notice of the upgrades 9/13/2007.

Device

Device Recall daVinci Surgical System Model IS1200, A4.3 SW level
  • 모델명 / 제조번호(시리얼번호)
    Systems manufactured or upgraded to Model IS1200 hardware/software level in this time frame: 2/17/2000 - 3/27/2007
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Romania, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
  • 제품 설명
    Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • 제조사 주소
    Intuitive Surgical, Inc., 1266 Kifer Rd, Sunnyvale CA 94086-5304
  • Source
    USFDA