Events

Maquet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular Us Sales, 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
    74915
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2746-2016
  • 사례 시작날짜
    2016-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148768
  • 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
    Post market surveillance cases reported to maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of maquet's connecting bracket (fixture) device is broken.
  • 조치
    Maquet sent an "Urgent Product Recall Medical Device Correction Letter and Medical Device Correction Response Form" dated August 12, 2016 via UPS to their affected customers. Customers were advised to inspect all devices that include the fixture for damage before every use. Customers were asked to fill out and sign the enclosed Medical Device Correction Response Form and return it via email to FieldAction@maquet.com or fax to 1-973-909-9927. Customers with questions were advised to contact their MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383. For questions regarding this recall call 973-709-7487.

Device

Maquet
  • 모델명 / 제조번호(시리얼번호)
    Part Number/Catalog Number 1002.64A0
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
  • 제품 설명
    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. || The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • 제조사 주소
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA