Events

Device Recall LICOX CMP Tissue Oxygen Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    57552
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1518-2011
  • 사례 시작날짜
    2010-12-17
  • 사례 출판 날짜
    2011-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96520
  • 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
    Intracranial Pressure Monitoring Device - Product Code GWM
  • 원인
    Certain licox cmp tissue oxygen monitors could allow for underestimation of temperature values.
  • 조치
    Integra Life Sciences notified their Integra Neurospecialist via email and their customers via Fed Ex overnight mail on December 17, 2010 with an Urgent: Product Recall letter. The letter identified the affected product and the reason for the recall. The letter states that an Integra Neurospecialist will contact customers to arrange for the return of their Licox monitor to the Service Center for recalibration. A loaner will be provided until the recalibration is complete. The attached "Recall Acknowledgement and Return Form" must be completed and returned to Integra. If there are any additional questions, customers should contact Gary Rabinovich at 609-936-6864.

Device

Device Recall LICOX CMP Tissue Oxygen Monitor
  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial numbers: 1982, 1988, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2003, 2005, 2007, 2008, 2009, 2010, 2011, 2012, 2014, 2046, 2047, 2051, and 2053.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, New Jersey 08536 USA. || Used for continuous determination of oxygen partial pressure in cerebrospinal fluid and brain tissue.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.