Events

Device Recall Pelton & Crane 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
    61262
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1177-2012
  • 사례 시작날짜
    2012-02-20
  • 사례 출판 날짜
    2012-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107682
  • 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
    Unit, operative dental - Product Code EIA
  • 원인
    Modification of the pelton & crane spirit 3000 unit disabled the tlc safedrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
  • 조치
    Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope.

Device

Device Recall Pelton & Crane
  • 모델명 / 제조번호(시리얼번호)
    Model #SET30, Catalog #3120, Serial numbers 4096 and 4099.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution
  • 제품 설명
    Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 || Product Usage: || The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up.
  • 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