Events

Device Recall QStation Quantification Software 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
    69790
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0818-2015
  • 사례 시작날짜
    2014-11-05
  • 사례 출판 날짜
    2014-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131546
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    When using the qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications, the reported end-systolic volume (esv) may be smaller, and the left ventricular ejection fraction (ef) may be higher, than the esv and ef calculated by manual tracing without the use of qlab. an incorrect ef calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
  • 조치
    Philips has identified additional affected units and sent the Urgent-Field Safety Notice -Philips Ultrasound QLAB 10.0 (on Xcelera) letter, dated 2015/3/17, to their consignees. The FCO associated with this letter is FSN MA-FCO 83000190. The affected units identified as QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. QLAB software installed on Philips diagnostic ultrasound systems (carts) is the subject of a separate Field Safety Notice (FSN MA-FCO79500316 ). Philips has corrected this issue with QLAB version 10.2 on Xcelera and will contact customers to arrange installation of the upgrade to version 10.2 or higher free of charge. If consignees need any further information or support concerning the FCO 83000190, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377. *************************************************************************************** Philips has begun sending out the URGENT - Medical Device Correction letters, dated 2014 NOV 05, for the Philips Ultrasound QLAB, Philips Model EPIQ 5 Ultrasound System, Philips Model EPIQ 7 Ultrasound System, and Philips Ultrasound Q-Station. The customer letter is also identified with the FSN # 79500316; 79500317; 79500318; or 79500321. The letters notified customers that Erroneous End-Systolic Volumes and Ejection Fraction May Be Reported When Using a2DQ & aCMQ (Auto 2D Quantification & Auto Cardiac Motion Quantification). Customers with questions should contact local Philips representative or Philips Customer Service at 1-866-767-7822.

Device

Device Recall QStation Quantification Software
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS FOR FCO 79500321- Q-Station Quantification Software SYSTEM:  16B7-KADBT53D-15A9, 196B-UAD585A1-159E, 1ED3-QACA8669-1588,  2187-VAC5T6CD-157D, 2C46-QADA8FF0-15A8, 2EFA-RAD51054-159D,  3716-IAC49180-157C, 41D5-NADA1AA3-15A7, 4489-SAD49B07-159C, 49F1-IAC99BCF-1586, 4CA5-UAC41C33-157B, 5764-MAD9A556-15A6, 5A18-QAD425BA-159B, 5CCC-HACEA61E-1590, 5F80-MAC92682-1585, 6CF3-WAD93009-15A5, 725B-GACE30D1-158F, 750F-TAC8B135-1584, 8282-JAD8BABC-15A4, 8536-IAD33B20-1599, 87EA-PACDBB84-158E, 8A9E-RAC83BE8-1583, 9811-WAD8456F-15A3, 9D79-WACD4637-158D, AAEC-MADD4FBE-15AD, ADA0-PAD7D022-15A2, B054-UAD25086-1597, B308-JACCD0EA-158C, B5BC-RAC7514E-1581, C07B-KADCDA71-15AC, C897-TACC5B9D-158B, D60A-GADC6524-15AB, D8BE-KAD6E588-15A0, DB72-RAD165EC-1595, DE26-WACBE650-158A, E0DA-XAC666B4-157F, EE4D-IAD6703B-159F, F3B5-IACB7103-1589, F669-PAC5F167-157E, H944-VACAFBB6-1589, MBF8-WAC57C1A-157E, T3DC-SAD5FAEE-159F, and Y690-GAD07B52-1594.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.
  • 제품 설명
    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. || Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
  • 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