Device Recall SUNDASH RADIUS 252 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 JK Products & Services, 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
    61869
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2334-2012
  • 사례 시작날짜
    2005-07-08
  • 사례 출판 날짜
    2012-09-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Booth, sun tan - Product Code LEJ
  • 원인
    The firm has tracked a systematic failure in the door cord on the sun|dash radius 252 product line. in some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.
  • 조치
    JK Global Services sent out Mandatory Inspection/Modification letters to their Distribution Service Teams dated 07/08/2005, 01/12/2006, 09/15/2010, 10/04/2010 and 03/01/2012. A letter dated September 15, 2010, was sent to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to contact a JK representative or their Distributor as soon as possible to schedule an inspection to the affected product in their possession. For any questions customers were instructed to call 1-800-445-0624 or send an e-mail to support@jkamerica.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    PN 8000809705; Serial numbers 248-1298
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Canada
  • 제품 설명
    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. || The device is intended to be used for tanning of the human skin.
  • Manufacturer

Manufacturer

  • 제조사 주소
    JK Products & Services, Inc, 1 Walter Kratz Dr, Jonesboro AR 72401-0609
  • Source
    USFDA