Events

Device Recall Philips Healthcare Brilliance iCT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    79666
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1408-2018
  • 사례 시작날짜
    2018-02-08
  • 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=162960
  • 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, x-ray, tomography, computed - Product Code JAK
  • 원인
    Closing the emergency stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
  • 조치
    The recalling firm notified customers of the recall on February 8, 2018, via Urgent Field Safety Notice. The notice advised customers of the issue and affected products and lot numbers. Customers were advised that once the E-stop has been closed, the operator/technologist must initate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Customers were informed that a Field Service Engineer would contact them to schedule site updates to correct the issue. Customers who need further information or support were advised to contact their local Philips representative. Additionally, they may contact the Customer Care Solutions Center (1-800-722-9377.

Device

Device Recall Philips Healthcare Brilliance iCT
  • 모델명 / 제조번호(시리얼번호)
    Serial No: 100410 100608 100611 100413 85071 100816 100667 85031 100654 100667 100604 100703 85031 85054 100672 100638 100616 100619 85078 100669 85048 85060 85062 100666 85058 85082 100304 85067 85063 100704 100769 100722 100600 100628 100771 100621 100627 100738 100615 100602 100617 100635 100624 100636 100696 100639 100651 100643 100642 100659 100640 100644 100669 100734 100662 100706 100716 100691 100711 100727 100683 100760 100677 100709 100692 100717 100678 100697 100687 100733 100732 100799 100736 100740 100778 100749 100809 100751 100762 100755 100746 100766 100763 100757 100765 100773 100783 100772 100775 100797 100780 100784 100787 100798 100786 100768 100612 100614 100622 100637 100656 100710 100666 100735 100680 100713 100707 100701 100698 100712 100785 100726 100776 100792 100745 100737 100767 100758 100781 100750 100814 100807 85015 85016 85026 85023 85022 85021 85081 85020 85044 85036 85037 85027 85045 85028 85047 85041 85040 85030 85048 85052 85051 85057 85053 85059 85055 85060 85062 85064 85065 85066 85075 85069 85068 85070 100310 85035 85042 85046 85063 85067 85072 85061 100730 100770 85032 100623 100646 100682 100051 85038 100402 85056 100652 85076 100650 100650 100688 100739 100661 100655 100664 100648 100803 100782 100673 100652 100725 100764 85025 100718 100742 100694 100714 100631 100681 100665 100684 100657 100754 100705 100720 100748 100645 100686 85080 85050 85077 85029 100721 100708 85039 100653 100603 100610 100653 100728 100747 100744 100700 100695 100685 100663 100794 85018 100759 100753 85033 100788 85019 100777 100719 100715 85034 85017 85049 100655 100668 100670 100668 100671 100670 100675 100674 85024 85043 100693 100368 100506 100802 100620 100779 100791 100606 100605 100607 100609 100613 100630 100676 100634 100633 100660 100743 100723 100731 100729 100679 100724 100702 100699 100761 100641 100647 100741 100690 100601 100626 100618 100629 100649 100658 100689 100675 100671 85059 100661 100672 100696 100101 100632 200045 100022 100374
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
  • 제품 설명
    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA