Events

Prism Laser 7642 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 American Stress Technologies, 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
    58804
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2600-2011
  • 사례 시작날짜
    2011-04-27
  • 사례 출판 날짜
    2011-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100331
  • 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
    Analytical measuring and detection laser product - Product Code REO
  • 원인
    It was discovered the prism 7642 was not certified at the time of delivery. the product lacks the required labeling and the product was sold and delivered without the submission of the initial product report. the product lacks user in formation.
  • 조치
    American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message. (2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011. (3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report. (4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message. If you have any further questions please call (724) 410-1030

Device

Prism Laser 7642
  • 모델명 / 제조번호(시리얼번호)
    S/N 7642/2009
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Prism Laser 7642 || Laser System
  • Manufacturer
    American Stress Technologies, Inc.

Manufacturer

American Stress Technologies, Inc.
  • 제조사 주소
    American Stress Technologies, Inc., 840 Watercrest Way, Cheswick PA 15024
  • 제조사 모회사 (2017)
    Nova Instruments Llc
  • Source
    USFDA