Events

Device Recall DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dental Equipment 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
    58122
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1958-2011
  • 사례 시작날짜
    2011-03-01
  • 사례 출판 날짜
    2011-04-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98425
  • 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
    dental chair - Product Code NRU
  • 원인
    Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
  • 조치
    On 03/08/11, Dental Equipment LLC. started sending out the Medical Device Recall notification letter via USPS 1st class mail to US consignees and Federal Express mail to foreign consignees. The firm also sent a recall notification letter to consignees who only purchased dental accessories such as Rear Mounted Cuspidor with Coverset, Arm Articulating Rear Mounted Cuspidor - Marus Gray, Maxstar Orbit Cuspidor utility W/ Porcelain bowl, and zinc plated bolts. The letter identified the affected dental chair as Marus brand with the following model numbers: DC1490, DC1690, DC1700 and DC1702. The firm's corrective action including the replacement of the affected link arm assembly with a new link arm assembly. The firm's field representative will contact each consignee for an appointment to replace the affected link arm assembly. Consignees can contact the Dental Equipment LLC at 503-537-3617 for any questions.

Device

Device Recall DCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirit
  • 모델명 / 제조번호(시리얼번호)
    Part number for the bolt: 022R065  Chair Serial Numbers: 1961, 2127, 2260, 239446, 239446, 240619, 241535, 242384, 242711, 242862, 244489, 244502, 244530, 244977, 245874, 246275, 246526, 247557, 247813, 247976, 248040, 248871, 249015, 249235, 249238, 249441, 249784, 218756C, 2250, 2251, 240126, 240126A , 240605, 240605A, 240605B, 240605C, 240605D, 240605E, 241379, 241379A, 241379B, 242154J, 242154K, 242154L, 245767, 245767F, 246769, 246769A , 247199AE, 247199AJ, 248129F, 248321, 248321A, 248378C, 248824, and 248824A.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution to USA, Australia, Canada, Ireland, South Africa, and Vietnam.
  • 제품 설명
    Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. || Part number for the bolt: 022R065 || Product is labeled in part: || DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, || Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, || Pelton & Crane, Spirit SP17.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • 제조사 주소
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA