Events

Device Recall AMS GreenLight PV Surgical Laser System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AMS Innovative Center - San Jose 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
    56058
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1229-2011
  • 사례 시작날짜
    2010-02-08
  • 사례 출판 날짜
    2011-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92557
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    A failure mode whereby the fiber attachment to the greenlight pv laser system could inadvertently be broken. if fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
  • 조치
    AMS Innovative Center - San Jose issued Important Product Update Information letters via express mail on February 8, 2010, and September 15, 2010 to all its direct consignees. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to attach the Fiber Guard to their GreenLight PV Laser System, and to complete the Response Form in the enclosed, self-addressed, postage paid envelope to AMS. For any questions regarding this recall call the Customer Care Department at 1-800-356-7600 or send an e-mail to CustomerCare@ammd.com.

Device

Device Recall AMS GreenLight PV Surgical Laser System
  • 모델명 / 제조번호(시리얼번호)
    All units of the model.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including US
  • 제품 설명
    AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; || Product is manufactured and distributed by AMS Solutions, || San Jose, CA || The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.
  • Manufacturer
    AMS Innovative Center - San Jose

Manufacturer

AMS Innovative Center - San Jose
  • 제조사 주소
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA