Events

Device Recall Maquet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular, 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
    76326
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1456-2017
  • 사례 시작날짜
    2017-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-04-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152788
  • 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
    Maquet has received several complaints involving the vasoview hemopro vh-3500 which involve the device exhibiting the failure mode of intermittent or no power.
  • 조치
    Maquet Inc. issued an Urgent Removal Correction Notice letter dated January 27, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory for affected device. Remove and keep it in a secure location to preclude being used. Customers were asked to complete the Medical Device Removal Response Form and return to Maquet by e-mailing a scanned copy to HemoproPower@getinge.com or by faxing the form to 1-973-629-1518.

Device

Device Recall Maquet
  • 모델명 / 제조번호(시리얼번호)
    25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    VASOVIEW HEMOPRO VH-3500 || ENDOSCOPIC VESSEL HARVESTING SYSTEM || Product Usage: || The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

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