Events

Device Recall Cardiogenesis Transmyocardial the SoloGrip III (HP5G3) and the PEARL 5.0 (HPPRL5). 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiogenesis Corporation 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
    66046
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1993-2013
  • 사례 시작날짜
    2011-05-01
  • 사례 출판 날짜
    2013-09-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121314
  • 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, laser, transmyocardial revascularization - Product Code MNO
  • 원인
    Following acquisition of cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
  • 조치
    Cardiogenesis is responsible for the correction of all noncompliant products. CDRH understands that the corrective action plan (CAP), involving 2,437 Sologrip III handpieces and 61 PEARL 5.0 handpieces, consists of the following: 1. Notification to purchasers of the handpiece removal and replacement procedures, 2. Replace existing hospital inventory of handpieces with a redesigned handpiece CDRH approves the CAP subject to the following conditions: 1. Notification of all distributors and purchasers will be successfully implemented, and 2. Corrections will be made at no cost to the purchasers by October 1, 2013. For further questions please call (949) 420-1800.

Device

Device Recall Cardiogenesis Transmyocardial the SoloGrip III (HP5G3) and the PEARL 5.0 (HPPRL5).
  • 모델명 / 제조번호(시리얼번호)
    Product Code - HP-SG3 Product Code -HP-PRL5
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. || The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.
  • Manufacturer
    Cardiogenesis Corporation

Manufacturer

Cardiogenesis Corporation
  • 제조사 주소
    Cardiogenesis Corporation, 1655 Roberts Blvd NW, Kennesaw GA 30144-3632
  • 제조사 모회사 (2017)
    Cryolife Inc.
  • Source
    USFDA