Events

Device Recall Coblator II System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ArthroCare Medical Corporation 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
    70594
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1323-2015
  • 사례 시작날짜
    2015-02-20
  • 사례 출판 날짜
    2015-03-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134100
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    The recalling firm was notified by the contract manufacturer that they had reversed the l2, l3, l4, or l5 components on the p/n09010 rohs boards of the coblator ii controller (model rf8000e).
  • 조치
    ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3.

Device

Device Recall Coblator II System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
  • 제품 설명
    Coblator II System, 120V. || Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
  • Manufacturer
    ArthroCare Medical Corporation

Manufacturer

ArthroCare Medical Corporation
  • 제조사 주소
    ArthroCare Medical Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA