Events

Device Recall MEDICYCLE Lite Portable Oxygen System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linde Gas North America Llc 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
    64856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1561-2013
  • 사례 시작날짜
    2013-03-08
  • 사례 출판 날짜
    2013-06-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117194
  • 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
    Regulator, pressure, gas cylinder - Product Code CAN
  • 원인
    A number of medicyl-e portable oxygen systems may have misapplied valve flow knobs.
  • 조치
    The firm, The Linde Group, sent a "Voluntary Medical Device Recall" letter dated June 21, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to view the enlarged photo on the reverse side of the notice for guidance. If you or your customers have a Unit with lot number 25/07, then please return it with the Product to your local LifeGas fill center as soon as possible. No other lot numbers are subject to this removal action. Customers with questions should contact Linde's Customer Care Center at 1-866-LIFEGAS (543-3427).

Device

Device Recall MEDICYCLE Lite Portable Oxygen System
  • 모델명 / 제조번호(시리얼번호)
    Model : Manufacturer's #M70500037 Cataogue Number: 109855   Lot numbers:  25/07 48/06 20/03
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    MEDICYCL-E- Lite Portable Oxygen System || An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
  • Manufacturer
    Linde Gas North America Llc

Manufacturer

Linde Gas North America Llc
  • 제조사 주소
    Linde Gas North America Llc, 575 Mountain Ave, Attn Import Compliance Manager, New Providence NJ 07974
  • 제조사 모회사 (2017)
    Linde AG
  • Source
    USFDA