Events

Device Recall Philips IntelliVue Clinical Information Portfolio 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    58182
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2175-2011
  • 사례 시작날짜
    2011-03-16
  • 사례 출판 날짜
    2011-05-10
  • 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=98612
  • 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
    patient data system - Product Code NSX
  • 원인
    Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.
  • 조치
    Philips Healthcare notified accounts on 3/16/11 via the Urgent Medical Device Correction Notification. Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. All customers potentially affected by this issue will receive the software correction as part of the field action.

Device

Device Recall Philips IntelliVue Clinical Information Portfolio
  • 모델명 / 제조번호(시리얼번호)
    versions D.03, E.0, or E.01 of the software
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Philips IntelliVue Clinical Information Portfolio software as follows: || 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA