Events

Device Recall Video Cart MultiSpecialty 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linvatec Corp. dba ConMed Linvatec 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
    56829
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0849-2011
  • 사례 시작날짜
    2010-02-23
  • 사례 출판 날짜
    2011-01-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94668
  • 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
    Camera, surgical and accessories - Product Code KQM
  • 원인
    Conmed linvatec, endoscopy division, dba. conmed linvatec, largo, florida is recalling five products: (1.) video cart premium 120 vac (vp6501), (2.) video cart multi-specialty 120 vac (vp6502), (3.) video cart articulating arm 120v (vp6504), (4.) video cart (vp8500), and (5.) power cord assembly self retracting (vp6547). these products are being recalled due to there is a possibility that the vid.
  • 조치
    ConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form. Customers were asked to document delivery of replacement plugs on the Sales Rep Reply Form and mail back or return by fax to 1-888-370-3062. For questions regarding this recall call the Customer Service Department at 1-888-292-0100 or e-mail Custserv1@Invatec.com.

Device

Device Recall Video Cart MultiSpecialty
  • 모델명 / 제조번호(시리얼번호)
    Video Cart Multi-Specialty (Catalog Number : VP6502)  Serial #: 04090102 04090202 04090302 04090402 04090502 04090602 04090702 04090802 04090902 04091002 04091102 04091202 04091302 04091402 04091502 04091602 04091702 04110102 04110202 04110302 04110402 04110502 04110602 04110702 04110802 04110902 04111002 04111102 04111202 04111302 04111402 04111502 04111602 04111702 04111802 04111902 05030102 05030202 05030302 05030402 05030502 05030602 05030702 05030802 05030902 05031002 05031102 05031202 05031302 05031402 05031502 05031602 05031702 05031802 05031902 05050102 05050202 05050302 05050402 05050502 05050602 05050802 05050902 05051002 05060102 05060202 05060302 05070102 05070202 05070402 05070502 05070602 05080102 05080202 05080302 05080402 05080502 05080602 05080702 05090102 05090202 05090302 05090402 05090502 05090602 05090702 06020102 06020202 06020302 06020402 06020502 06020602 06020802 06020902 06021002 06040102 06040202 06040302 06040402 06040502 06050102 06050202 06050302 06050402 06050502 06050602 06050702 06050802 06050902 06070102 06070202 06070302 06070402 06070502 06070602 06080102 06080202 06080302 06080402 06080502 06080602 06080702 06080802 06080902 06081002 06090102 06090202 06090302 06090402 06090502 06090602 06090702 06090802 06090902 06091002 06091102 06091202 06100102 06100202 06100302 06100502 06100702 06100802 06100902 06101002 06101102 06110102 06110202 06110302 06110402 06110502 06110602 06110702 06110802 06110902 06111002 06111102 06111202 06111302 06111402 06111502 06111602 06111702 06111802 06120102 06120202 06120302 06120402 07120102 08010102 08010202 08010302 08010402
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela.
  • 제품 설명
    Video Cart Multi-Specialty product labeling is as follows: || REF, VP6502, QTY1, Video Cart Multi-Specialty, 120V, Rx ONLY, || These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties || MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • 제조사 주소
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA