Events

Device Recall daVinci S Surgical System IS2000 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
    38311
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0079-2008
  • 사례 시작날짜
    2007-03-30
  • 사례 출판 날짜
    2008-02-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-09-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53387
  • 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
    Surgical Endoscopic Instrument Control System - Product Code NAY
  • 원인
    System lock-up: software anomalies could cause product failure during use, or on start-up. system transitions to a safe "soft-lock" state.
  • 조치
    Intuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.

Device

Device Recall daVinci S Surgical System IS2000
  • 모델명 / 제조번호(시리얼번호)
    Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1. System Numbers: all starting with "SG"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.
  • 제품 설명
    Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • 제조사 주소
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA