Events

Device Recall Video Cart Articulating Arm 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-0850-2011
  • 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=94669
  • 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 Articulating Arm
  • 모델명 / 제조번호(시리얼번호)
    Video Cart Articulating Arm (Catalog Number : VP6504)  Serial Number: 05080104 05080204 05080304 05080404 05080504 05080604 05080704 05080804 05090104 05090204 05090304 05090404 05090504 05090604 05090704 05090804 05090904 05091104 05091204 05110104 05120104 05120204 05120304 05120404 05120504 05120604 05120704 05120804 05120904 05121004 06020104 06020204 06020304 06020404 06020504 06020604 06030104 06030204 06030304 06030404 06040104 06040204 06040304 06040504 06040604 06040704 06040804 06040904 06041004 06060104 06060204 06060304 06060404 06060504 06070104 06070404 06070504 06070604 06080104 06080204 06080304 06080504 06080604 06090104 06090204 06090304 06090404 06090504 06090604 06100104 06100204 06100304 06100404 06100504 06100704 06100804 06100904 06101004 06101104 06101204 06101304 06101404 06110104 06110204 06110304 06110404 06110504 06110604 06110704 06110804 06110904 06111004 06120104 06120204 06120304 06120404 06120504 06120604 06120704 06120804 06120904 06121004 06121104 06121204 07070104 07070204 07070304 07070404 07070504 07070604 07070704 07070804 07070904 07071004 07071104 07080104 07080204 07080304 07080404 07080504 07100104 07100204 07100304 07100404 07100504 07100604 07100704 07100804 07100904 07101004 07110104 07110204 07110304 07110404 07110504 07110604 07110704 07110804 07110904 07111004 07111104 07111204 07111304 07120104 07120204 07120304 07120404 07120504 07120604 07120704 07120804 07120904 07121004 07121104 07121204 07121304 07121404 07121504 08010104 08010204 08010304 08010404 08010504 08010604
  • 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 Articulating Arm product labeling is as follows: || REF, VP6504, QTY1, Video Cart Articulating Arm, 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