Events

EPIQ 5 Ultrasound System iwth Pediatric Cardiology option 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
    71084
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1578-2015
  • 사례 시작날짜
    2015-04-10
  • 사례 출판 날짜
    2015-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136055
  • 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
    When epiq 5 ultrasound system, with the pediatric cardiology option, is set up to metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients body surface area (bsa).
  • 조치
    Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 and Ultrasound system letter, dated 2015 APRIL 10, and the Urgent-Medical Device Correction-Philips Model EPIQ7 and Ultrasound system letter, dated 2015 APRIL 10, letters to their consignees. These systems WITH Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500336 for EPIQ5 -FCO 79500337 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377.

Device

EPIQ 5 Ultrasound System iwth Pediatric Cardiology option
  • 모델명 / 제조번호(시리얼번호)
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USO14C0158, USO14C0159, USO14C0160, and USO14C0188.   *****************************SYSTEM CODES IN CANADA********************  US115C0274, US115C0466, US115C0467, US115C0494, US214C0486, US215C0034, US215C0036, US215C0347, US414C0111, US414C0112, US414C0113, US414C0114, US414C0477, US414C0478, US514C0339, US614C0688, US614C0854, US914C0179, US914C0180, USN14C0237, and USO14C1093.   ****************************SYSTEM CODES IN OTHER COUNTRIES*************  US114C0077, US114C0078, US114C0079, US114C0080, US114C0105, US114C0106, US114C0109, US114C0190, US114C0191, US114C0284, US114C0285, US114C0361, US114C0362, US114C0365, US114C0378, US114C0405, US114C0406, US114C0407, US114C0443, US114C0505, US114C0531, US114C0533, US114C0672, US114C0673, US114C0675, US114C0730, US114C0751, US115C0018, US115C0055, US115C0097, US115C0098, US115C0099, US115C0215, US115C0275, US115C0383, US115C0449, US115C0450, US115C0463, US115C0564, US115C0566, US115C0573, US115C0574, US115C0616, US115C0647, US115C0648, 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
  • 제품 설명
    EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With || 453561736761 (1.1) || 453561750041 (1.1.1) || 453561753651 (1.1.2) || 453561772231 (1.2) || 453561772611 (1.2.1) || 453561786571 (1.2.2) || 453561785081 (1.3) || 453561800581 (1.3.1) || 453561805181 (1.3.2)
  • 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