Device Recall Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Penlon, Ltd. 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
    60647
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1318-2012
  • 사례 시작날짜
    2011-11-29
  • 사례 출판 날짜
    2012-03-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • 원인
    Penlon, ltd has identified the potential for the premature failure of a component in some electronic flowmeter sensor display unit pcb assemblies.
  • 조치
    Penlon Limited sent a Technical Bulletin dated November 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. As a precaution a field upgrade part was released that required all existing PCB assemblies to be removed and the updated item installed. The old PCB must be returned to Penlon with the serial number of the affected machine. The required replacement parts were included with the technical bulletin. For further information customers should contact the Technical Support Team at techsupport@penlon.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    None
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Peru, Uganda, Kenya, Malaysia, Poland, Saudi Arabia, United Arab Emirates, Philippines, Equador, and Thailand
  • 제품 설명
    Anesthesia Machines (digital display assembly); || A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
  • Manufacturer

Manufacturer