Events

Dermalight 80, UVB083 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 National Biological Corp 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
    65494
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1779-2013
  • 사례 시작날짜
    2013-04-08
  • 사례 출판 날짜
    2013-07-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119281
  • 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
    Lamp, infrared, non heating - Product Code FTC
  • 원인
    The incorrect manual may have been packaged with this product. uvb-083 devices may have included the manual for a uva-080 device.
  • 조치
    The firm, National Biological, sent an "VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated May 10, 2013 to its consignees/customers by UPS or other delivery service with a signature required. The letter described the product, problem and actions to be taken. Consignees/customers who do not respond to the letter will be contacted via telephone. The customers were instructed to check within your household to determine if you have any of the listed product; immediately destroy the incorrect User Manual, it is not necessary to return the product; record the Customer Name and or the Dermalight-80 serial number and complete and return the enclosed Verification Form, even if you do not have any User Manuals to destroy. Please contact your National Biological Corporation sales representative if you have any questions regarding this recall, any of our products, or would like assistance with the recall call 216-831-0600 or 800-338-5045 email: infor@PhototherapyExperts.com.

Device

Dermalight 80, UVB083
  • 모델명 / 제조번호(시리얼번호)
    The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution including the states of: AL, CA, MN, and NC.
  • 제품 설명
    Dermalight 80 Model Number UVB-083, one unit per box. || The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
  • Manufacturer
    National Biological Corp

Manufacturer

National Biological Corp