Events

Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sechrist Industries 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
    52796
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0208-2013
  • 사례 시작날짜
    2008-08-28
  • 사례 출판 날짜
    2012-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84024
  • 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
    Chamber, hyperbaric - Product Code CBF
  • 원인
    Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with electronic control modules in order to correct a software bug that could potentially affect the performance of the chamber.
  • 조치
    Sechrist Industries contacted consignees by phone to notify them of a software upgarde and to schedule appointments to perform the required field upgrades. An approximate summary of the phone notification is provided below. "I am contacting you to notify you of a field upgrade we are performing on our hyperbaric chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of your chamber. The upgrade includes the installation of a new motherboard with revised software, a reset switch, and the exchange of other control panel components. The process will take approximately 2.5 hours and will be performed at no charge to you." For questions regarding this recall call 714-579-8400.

Device

Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
  • 제품 설명
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER || The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • 제조사 주소
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807
  • 제조사 모회사 (2017)
    Sechrist Industries Inc.
  • Source
    USFDA