Events

Device Recall Video Cart, Premium 120V 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.

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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-0848-2011
  • 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=94666
  • 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, Premium 120V
  • 모델명 / 제조번호(시리얼번호)
    Video Cart, Premium 120V (Catalog Number : VP6501)  Serial Numbers: 04080101 04080201 04080301 04080401 04080501 04080601 04080701 04080801 04080901 04081001 04081101 04081201 04081301 04081401 04090101 04090201 04090301 04090501 04090601 04090701 04090801 04090901 04110101 04110201 04110301 04110401 04110501 04110601 04110701 04110801 04110901 04120101 04120201 04120301 04120401 04120501 04120601 04120701 04120801 04120901 05020101 05020201 05020301 05020401 05020501 05020601 05020701 05020801 05020901 05021001 05021101 05021201 05021301 05021401 05021501 05021601 05021701 05040101 05040301 05040401 05040501 05040601 05040701 05040801 05040901 05041001 05041101 05041201 05041301 05041401 05041501 05041601 05050101 05050201 05050301 05050401 05050501 05050601 05050701 05050801 05060101 05060201 05060301 05060401 05060501 05070101 05070201 05070301 05070401 05070501 05070601 05080101 05080201 05080301 05080401 05080501 05080601 05080701 05080801 05080901 05081001 05081101 05081201 05081301 05081401 05081501 05081601 05081701 05081801 05081901 05100101 05100201 05100301 05100401 05100501 05100601 05110101 05110201 05110301 05110401 05110601 05110701 05110801 05110901 05111001 05111101 05111201 05111301 05111401 05120101 05120201 05120301 05120401 05120501 05120601 05120701 05120801 05120901 05121001 06020101 06020201 06020301 06020401 06020501 06020601 06020701 06020801 06020901 06021001 06021101 06021201 06021301 06021401 06021501 06021601 06021701 06021801 06030101 06030201 06030301 06040101 06040201 06040301 06040401 06040501 06040601 06040701 06040801 06040901 06041001 06041101 06041201 06041301 06041401 06041501 06041601 06041701 06041801 06041901 06042001 06042101 06042201 06042301 06042401 06042501 06042601 06042701 06042801 06042901 06050101 06050201 06050301 06050401 06050501 06050601 06050701 06050801 06050901 06051001 06051101 06051201 06060101 06060201 06060301 06060401 06060501 06060601 06060701 06060801 06060901 06061001 06061101 06061201 06061301 06061401 06061501 06061601 06061701 06070101 06070201 06070301 06070401 06070501 06070601 06070701 06070801 06070901 06071001 06080101 06080201 06080301 06080401 06080501 06080601 06080701 06080801 06080901 06090101 06090201 06090301 06100101 06100201 06100301 06100401 06100501 06100601 06100701 06100801 06100901 06101001 06101101 06101201 06101301 06101401 06101501 06101601 06101701 06101801 06101901 06102001 06102101 06102201 06102301 06102401 06102501 06102601 06102701 06102801 06102901 06103001 06103101 06103201 06103301 06110101 06110201 06110301 06110401 06110501 06110601 06110701 06110801 06110901 06111001 06111101 06111201 06111301 06111401 06111501 07030101 07030201 07030301 07030401 07030501 07030601 07030701 07030801 07031001 07031101 07040101 07040201 07040301 07040401 07040501 07040601 07040701 07080101 07080201 07080301 07100101 07100201 07100301 07100401 07100501 07100601 07100701 07100801 07100901 07101001 07101101 07101201 07101301 07101401 07110101 07120101 07120201 07120301 07120401 07120501 08010101 08010201 08010301 08010501 08010601
  • 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, Premium 120V product labeling is as follows: || REF, VP6501, QTY1, Video Cart, Premium, 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