Events

Device Recall Intracranial pressure monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spiegelberg Gmbh & Co. KG 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
    75160
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2888-2016
  • 사례 시작날짜
    2009-12-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149491
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • 원인
    In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. because of these false high readings were displayed in the lower measuring range from 0 to 20 mmhg. the observed measurement error was particularly at the lowest end of the range (to 0 mmhg) up to 8 mmhg.
  • 조치
    Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products. Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them.

Device

Device Recall Intracranial pressure monitor
  • 모델명 / 제조번호(시리얼번호)
    Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393;  Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to PA only
  • 제품 설명
    Spiegelberg Brain Pressure Monitoring System || Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P || Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
  • Manufacturer
    Spiegelberg Gmbh & Co. KG

Manufacturer

Spiegelberg Gmbh & Co. KG
  • 제조사 주소
    Spiegelberg Gmbh & Co. KG, Tempowerkring 4, Hamburg Germany
  • 제조사 모회사 (2017)
    Spiegelberg GmbH & Co. KG
  • Source
    USFDA