Events

Device Recall Nuclear, Magnetic Resonance Imaging 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Electronics North America Corporation 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
    79451
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1433-2018
  • 사례 시작날짜
    2018-03-16
  • 사례 출판 날짜
    2018-04-18
  • 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=162718
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • 조치
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff

Device

Device Recall Nuclear, Magnetic Resonance Imaging
  • 모델명 / 제조번호(시리얼번호)
    (Added 6/25/18): 8920 8590 8368 8210 10049 8277 10039 10087 8302 18629 8050 18749 10777 8699 18554 8250 8073 8540 18050 10691 18784 8056 10198 8244 8583 8889 18079 8408 10031 8052 8899 8234 10137 18974 10014 8612 8916 10133 8928 10789 18966 10118 10195 8009 8846 8668 8797 10092 10732 8233 18034 8003 18723 8418 8934 10111 8536 8268 8462 10727 30047 8893 10721 10221 8670 8216 18667 30098 8721 8569 8666 10010 18860 8691 8888 8898 8975 8080 10729 8198 8963 18030 8872 18578 8037 8788 18549 10167 8043 10097 8951 8544 8432 8626 8655 18579 8316 8744 10005 8482 8827 8856 8403 10695 8320 18725 10707 10144 8836 8995 18110 18025 18031 9011 10105 10722 10724 8184 8176 10786 10100 8366 8112 8301 10697 8772 10217 18100 8255 8141 8414 8436 18728 8585 8101 8332 10677 8841 10726 10693 8019 8850 8269 18642 18065 18750 10803 8631 8937 9034 18093 18662 8818 8859 8603 18539 8128 18677 18661 8252 8412 8206 8356 8131 8295 8018 8618 18868 8789 8274 8785 10687 10708 8778 8805 8710 10675 18782 8338 10074 8400 8104 10078 8754 8279 8214 8991 8225 10711 10775 8768 30017 8181 18864 8567 9010 8152 8925 8998 10218 18569 10700 8926 8580 10794 8665 8781 8615 10154 10704 8563 8954 8067 8557 30032 18822 18702 8227 10121 8564 10689 30056 8384 10494 18563 18523 18568 8931 10228 10797 18070 10024 8064 8693 8950 18585 8674 10540 8495 8145 8159 8997 10212 10069 8837 18653 8376 10107 8560 10788 8342 8537 8063 18593 18534 8373 10090 8160 8952 8910 8908 8048 8987 18522 8102 8410 18922 18516 8676 10709 10792 8370 10232 8219 8174 8494 8835 10081 8296 8218 8093 18600 10214 8672 8047 8375 8617 8737 8891 18756 10702 10681 8224 18097 8030 10690 10785 8113 8146 10204 8256 8543 8562 10692 10710 10041 8599 18972 30030 18616 18036 8382 8026 8430 8509 8144 8304 10460 18656 8945 8717 18029 8527 18606 8596 8698 10581 18011 10122 8918 8849 8915 8130 18074 10034 10159 10627 18562 8638 8685 18901 8335 8217 8314 18615 8630 8613 8237 10052 8815 10725 10131 10009 8483 18726 8833 8542 18628 8016 8238 18865 8738 10795 8643 10799 10462 10013 18729 8027 10089 18546 10696 8151 18049 8635 8505 10787 10119 8082 18973 10209 10124 8906 8246 8133 8549 10098 10227 8565 18581 8013 8257 8423 8762 18108 18021 18032 8360 8469 18012 8548 9008 8530 8049 8733 10196 8459 18553 8085 10213 8125 8633 8534 10068 8394 8838 8352 10056 8972 18660 8413 8278 8333 8806 8760 10219 8235 8254 8140 10035 10684 8034 18559 10112 10088 8708 8764 8503 8199 8357 8005 8930 8281 10003 18092 8577 8500 8372 10790 10676 18939 18900 8341 10685 10723 8340 8042 8956 18786 8383 8406 8647 8024 8735 10206 8008 8649 8688 8079 10682 18876 8473 10678 8650 8909 18650 18519 18640 8154 8621 10093 18659 8380 10783 8933 8883 8866 8023 18918 18536 8359 8522 18582 10798 8098 10057 8636 18558 18607 8100 18668 8041 10036 8970 8515 9001 8988 18902 8038 10482 18863
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Republic of Korea - South Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lesotho, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen & Zimbabwe.
  • 제품 설명
    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) || Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, || 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA