Events

Device Recall High Power Handheld Laser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 United Nuclear Scientific Supplies, 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
    78389
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0051-2018
  • 사례 시작날짜
    2016-08-25
  • 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=159398
  • 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
    Laser pointer - Product Code REA
  • 원인
    Failure to comply with the laser class limitation listed in the performance standard for specific use laser products.
  • 조치
    United Nuclear will bring defect into compliance by : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving three units will consist of the following: 1. Notification will be given to purchasers per 21 CFR 1003.21. 2 .A full refund will be offered to all purchasers upon return of their laser pointers. 3. Postage paid shipping containers will be provided to all purchasers for the return of the laser pointers. Please note that United Nuclear Scientific Supplies, LLC is responsible for the correction of all noncompliant products If you have any questions, please call (517) 339-3587, or email : sales@unitednuclear.com

Device

Device Recall High Power Handheld Laser
  • 모델명 / 제조번호(시리얼번호)
    Surveying Leveling and Alignment (SLA) laser products
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    United Nuclear Scientific High Power Handheld Lasers. || Laser products
  • Manufacturer
    United Nuclear Scientific Supplies, LLC

Manufacturer

United Nuclear Scientific Supplies, LLC
  • 제조사 주소
    United Nuclear Scientific Supplies, LLC, 16429 Upton Rd, Suite #1, East Lansing MI 48823-9327
  • Source
    USFDA