Events

Device Recall Philips Lumify Diagnostic Ultrasound 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Ultrasound, 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
    72879
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0596-2016
  • 사례 시작날짜
    2015-12-09
  • 사례 출판 날짜
    2016-01-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142399
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    Color flow direction is displayed incorrectly in lumify 1.0. the system displayed color flow direction does not correctly represent the annotated color bar or velocity markers. (e.G.) when the color bar conveys that red is to be displayed for color flow toward the transducer, the system displays blue for color flow toward the transducer. this could result in misdiagnosis in some studies.
  • 조치
    Philips began mailing the URGENT - Medical Device Correction Philips Model Lumify Ultrasound System, FSN 79500372, dated 2015 DEC 11, to consignees. Consignees are instructed to do the following: 1. Check the version of software on your system using the instructions provided above on How to Identify Affected Products. Philips has corrected this issue in version 1.0.1 and higher. 2. Connect the tablet to the internet. 3. The system will alert you to download the upgrade from Google Play. 4. Follow all on screen to upgrade the software version. If consignees cannot promptly connect to the internet to download the upgraded software, Philips recommends that you do not use Color Flow. In accordance with the subscription terms and conditions, you will be required to reconnect the system to the internet within no more than 30 days. If consignees do not connect their device to the internet after 30 days, they will be unable to use the system. Consignees with questions should contact your local Philips representative or Philips Customer Service at 1-800-722-9377.

Device

Device Recall Philips Lumify Diagnostic Ultrasound
  • 모델명 / 제조번호(시리얼번호)
    System Serial numbers:  USD15L0177; USD15L0178; USD15L0179; USD15L0297; USD15L0298; USN15L0789; USN15L0862; USN15L0863; USN15L0864; USN15L0865; USN15L0866; USN15L0867; USN15L0917; USN15L0918; USN15L0988; USO15L0563; USO15L0564; USO15L0565; USO15L0566; USO15L1087; and USO15L1088.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    distributed in CA, CT, ND, NV, OR, RI, TN, and WA.
  • 제품 설명
    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 || Part Number: 989605449841 with 453561845331 (software version 1.0)
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • 제조사 주소
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA