Events

Maquet Medical Systems USA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Medical Systems USA 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
    75386
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0390-2017
  • 사례 시작날짜
    2016-10-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150184
  • 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, operating-room, ac-powered - Product Code FQO
  • 원인
    Maquet inc. is initiating a voluntary field action on the accessory adapter part number 600525a0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
  • 조치
    Maquet Medical Systems USA sent an Urgent Product Recall Medical Device Removal letter dated October 5, 2016 to the affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Read this Medical Device Removal Notice and disseminate the information provided to all the users of the device. 2. Examine your inventory immediately to determine if you have the Accessory Adapter(s). If so, remove the affected products, quarantine them and keep them in a secure location for shipment back to Maquet. 3. Please fill out and sign the enclosed Medical Device Removal Response Form on page 4 and return it either via email to FieldActions@maquet.com or fax to 1-973-909-9927. For question contact your local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Press option 2, then followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EDT.

Device

Maquet Medical Systems USA
  • 모델명 / 제조번호(시리얼번호)
    600525A0
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
  • 제품 설명
    Accessory Adapter Part number 600525A0 || Product Usage: || designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA
  • 제조사 주소
    Maquet Medical Systems USA, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA