Events

Device Recall Vycor Medical ViewSite Brain Access System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vycor Medical, Inc. 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
    63319
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0673-2013
  • 사례 시작날짜
    2012-08-21
  • 사례 출판 날짜
    2013-01-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113513
  • 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
    Retractor, self-retaining, for neurosurgery - Product Code GZT
  • 원인
    Vycor medical recalled their vbas (vycor viewsite brain access system) because an unidentified black fiber was found on the device.
  • 조치
    Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.

Device

Device Recall Vycor Medical ViewSite Brain Access System
  • 모델명 / 제조번호(시리얼번호)
    Model # TC171105 Lot # VM83450
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
  • 제품 설명
    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** || Product Usage: || The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
  • Manufacturer
    Vycor Medical, Inc.

Manufacturer

Vycor Medical, Inc.
  • 제조사 주소
    Vycor Medical, Inc., 6401 Congress Ave Ste 140, Boca Raton FL 33487-2841
  • 제조사 모회사 (2017)
    Vycor Medical, Inc.
  • Source
    USFDA