Events

Device Recall Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pelton & Crane Company 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
    54809
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1311-2010
  • 사례 시작날짜
    2010-02-09
  • 사례 출판 날짜
    2010-04-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-08-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89221
  • 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
    Spirit 3000 dental chair - Product Code KLC
  • 원인
    The dental chair lacks a valid device history record.
  • 조치
    An "URGENT MEDICAL DEVICE RECALL" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA. Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored.

Device

Device Recall Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 3003, Model number: SP30, Chair Serial #14736
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: NC
  • 제품 설명
    Pelton & Crane Spirit 3000 Dental Chair. || The intended use of this device is for properly positioning patients to perform dental procedures.
  • Manufacturer
    Pelton & Crane Company

Manufacturer

Pelton & Crane Company
  • 제조사 주소
    Pelton & Crane Company, 11727 Fruehauf Dr, Charlotte NC 28273
  • 제조사 모회사 (2017)
    Pelton & Crane Company
  • Source
    USFDA