Events

Device Recall Accu2i pMTA Applicator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics, 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
    77631
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0528-2018
  • 사례 시작날짜
    2017-06-05
  • 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=156975
  • 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
    System, ablation, microwave and accessories - Product Code NEY
  • 원인
    The firm is recalling product that has the potential to not function during use. the product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code high reflective power displayed on the microwave generator.
  • 조치
    URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017. The letter identified the affected product, problem and actions to be taken.

Device

Device Recall Accu2i pMTA Applicator
  • 모델명 / 제조번호(시리얼번호)
    Lots: 15310413, 15320415, 15340429, 15350431, 15360432, 15370435, 15380440, 15390444, 15400450, 15430456, 15440460, 15460467, 15470469, 15480471, 15490477, 15500481, 15520484, 16010489, 16050495, 16070500, 16080503, 16090506, 16100509, 16120513, 16150521, 16160523, 16170529, 16190534, 16230548, 16240551, 16250557, 16270563, 16300569, 16310571, 16320575, 16330577, 16350582, 16350586, 16370591, 16390596, 16410602, 16430610, 16440613, 16450618, 16460619, 16500636, 16510644, 17020651, 17040658, 17050660, 17060663, 17070668, 17100674, 17110678,  17130685.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - US Nationwide
  • 제품 설명
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • 제조사 주소
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA