Events

Philips 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    50088
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0817-2009
  • 사례 시작날짜
    2008-10-22
  • 사례 출판 날짜
    2009-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74699
  • 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
    Table Mount - Product Code DSI
  • 원인
    Table mounts assembled with incorrect length hardware may fall.
  • 조치
    Philips issued an "Urgent Medical Device Correction" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method. The letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Service Engineer, they are instructed to make sure that the monitor is not in a position to fall. They are asked to disconnect the monitor from the table mount. For additional information, contact Philips Medical Systems at 1-978-687-1501.

Device

Philips
  • 모델명 / 제조번호(시리얼번호)
    Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit  M8040A option E22 Quick release kit for MP20MP30  A list of S/N's can be obtained fromthe recalling firm.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Canada Foreign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland,Portugal, Russia, Saudia Arabia, Singapore, Slovenia South Africa, Spain.,. Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia
  • 제품 설명
    Philips M8000-64100 Table Mount || Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. || Product shipped between 6/03/08 and 9/12/08 as follows: || M1013A IntelliVue G1 Gas Module || M1019A IntelliVue GS Gas Module || M8001A option E22 Quick release mount for IntelliVue MP20 || M8002A option E22 Quick release mount for IntelliVue MP30 || M8003A IntelliVue MP40 || M8004A IntelliVue MPSO || M8005A IntelliVue MP60 || M8007A IntelliVue MP70 || M8105A option E22 IntelliVue MP5 Quick Release Mount || M8105AT option E22 IntelliVue MPST Quick Release Mount || M8040A option U02 U02 Table top mount kit || M8040A option E22 Quick release kit for MP20MP30 || The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA