Events

Device Recall Viasys Vela Adult/Pediatric Lung Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Viasys Respiratory Care, Inc.dba Bird Products 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
    37318
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0638-2007
  • 사례 시작날짜
    2007-01-31
  • 사례 출판 날짜
    2007-03-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-09-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50340
  • 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
    Ventilator - Product Code CBK
  • 원인
    The graphical user interface may become slow in its response and in some cases non-responsive. under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
  • 조치
    On January 31, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks

Device

Device Recall Viasys Vela Adult/Pediatric Lung Ventilator
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: AGT03640 thru AGT06049
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.
  • 제품 설명
    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
  • Manufacturer
    Viasys Respiratory Care, Inc.dba Bird Products

Manufacturer

Viasys Respiratory Care, Inc.dba Bird Products
  • 제조사 주소
    Viasys Respiratory Care, Inc.dba Bird Products, 1100 Bird Center Dr, Palm Springs CA 92262-8000
  • Source
    USFDA