Events

Device Recall Apollo 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Villa Radiology Systems LLC 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
    73459
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1064-2017
  • 사례 시작날짜
    2016-02-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144236
  • 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
    Table, radiologic - Product Code KXJ
  • 원인
    The analysis showed that the incident was caused by a chain of four faults: 1.) the injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) the directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) the movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) delayed activation of the emergency stop.
  • 조치
    Consignees were notified of the recall via letter starting on 2/19/16. The letter explains the issue and actions to be taken by the consignee and manufacturer.

Device

Device Recall Apollo
  • 모델명 / 제조번호(시리얼번호)
    06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI
  • 제품 설명
    Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 || Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
  • Manufacturer
    Villa Radiology Systems LLC

Manufacturer

Villa Radiology Systems LLC
  • 제조사 주소
    Villa Radiology Systems LLC, 91 Willenbrock Rd Ste B1, Oxford CT 06478-1036
  • 제조사 모회사 (2017)
    Villa Radiology Systems Llc
  • Source
    USFDA