Events

Device Recall VisualICE Cryoablation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Galil Medical, 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
    62871
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2261-2012
  • 사례 시작날짜
    2012-07-20
  • 사례 출판 날짜
    2012-08-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111916
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • 원인
    Galil medical is recalling a number of visual ice cryoablation systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
  • 조치
    Galil Medical sent a "Voluntary Medical Device Field Correction" letter dated July 20, 2012, via UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Galil Field Service team will be contacting customers to schedule a service visit the week of July 23rd. Customers were instructed to forward and communicate this field correction notice and instructions to individuals in their organization and/or to other organizations affected by this action. For questions call Galil Medical Customer Service.

Device

Device Recall VisualICE Cryoablation System
  • 모델명 / 제조번호(시리얼번호)
    VL0004 VL0014 VL0015 VL0016
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
  • 제품 설명
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 || Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
  • Manufacturer
    Galil Medical, Inc.

Manufacturer

Galil Medical, Inc.
  • 제조사 주소
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • 제조사 모회사 (2017)
    Btg Plc
  • Source
    USFDA