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
    36489
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0184-2007
  • 사례 시작날짜
    2006-09-21
  • 사례 출판 날짜
    2006-11-16
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48751
  • 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
    physiological monitoring system - Product Code DQA
  • 원인
    Unexpected pulse oximetry (sp02) readings (100%) over time when sensor is not attached to patient. in addition, with a sensor attached to a patient, an incorrect high sp02 may be displayed when a pulse rate is in a range of 185bpm.
  • 조치
    Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.

Device

Philips
  • 모델명 / 제조번호(시리얼번호)
    M1020B #AO01 AND #A02 with S/N DE524xxxxx M102B #A01 and #A02 with S/N DE612xxxxx With Sp02 Firmware (Fw) Rev: Sp02 DSP Fw-Rev. A.01.42
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Canada, Australia, China, Hong Kong, India, Indonesia, Japan, Phillipines, Singapore, Taiwan, Thailand, Vietnam, Argentina, Brazil, Chile, Colombia, El Salvador, Jamaica, Mexico, Nicaragua. Panama, Paraguay, Peru, Venezuela, Austria, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Mauritania, Mauritius, Netherlands, Norway, Oman, Slovenia, South Africa, Spain, Switzerland, Turkey, UAE, UK, Yemen, Zambia, Zimbabwe
  • 제품 설명
    M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810-1032
  • Source
    USFDA