Events

Device Recall 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
    49005
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2369-2008
  • 사례 시작날짜
    2008-07-22
  • 사례 출판 날짜
    2008-09-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72508
  • 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
    Oximeter - Product Code DQA
  • 원인
    Software: if weight limits edited, values will return to default values that were deleted.
  • 조치
    Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.

Device

Device Recall Philips
  • 모델명 / 제조번호(시리얼번호)
    Software Revision: B.02.07
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Philips Telemonitoring System Software (M3811B) used with || Philips Telemonitoring System (M3810B) || Revision: B.02.07 || Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.
  • 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