Events

Device Recall Blease Sirius Anaesthesia Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, 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
    57348
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0813-2011
  • 사례 시작날짜
    2009-06-25
  • 사례 출판 날짜
    2010-12-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95923
  • 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
    Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the left hand mounted vapouriser on the blease sirius anaesthesia systems.
  • 조치
    Spacelabs Healthcare issued an URGENT MEDICAL DEVICE CORRECTION letter dated June 25, 2009 to the two consignees in the US. Spacelabs Healthcare UK notified consignees outside the US. The consignees were advised to brief their staff about the issue and test the Anesthesia Systems in advance of a procedure. If there is an issue with turning on a vaporizer in the left hand position, simply move the vaporizer to the right hand position. The firm contacted their consignees for a schedule to replace the flowmeter mouldings. The US consignees can contact Spacelabs Healthcare Representatives at 425-657-7200 ext. 5089 about this recall. Foreign consignees can contact Spoacelabs at 44 1494 784422.

Device

Device Recall Blease Sirius Anaesthesia Systems
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: SIRI-000845, SIRI-000862, SIRI-000869, SIRI-000885, and SIRI-000898.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US in the states of LA and SD, and internationally by Spacelabs Healthcare, Ltd in the countries of China, Czech Republic, Hong Kong, India, Poland, Saudi Arabia, Singapore, and the United Kingdom.
  • 제품 설명
    Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously.. || The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018".
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA