Events

Brilliance iCT, Model No. 728306 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
    74131
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2381-2016
  • 사례 시작날짜
    2016-04-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146400
  • 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
    Software issues in versions v4.1 .3/4.1.5 in the philips brilliance ict) ict sp products that, could affect the performance of the equipment.
  • 조치
    The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.

Device

Brilliance iCT, Model No. 728306
  • 모델명 / 제조번호(시리얼번호)
    Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725 100726 100727 100728 100105 100123 100130 100132 100141 100146 100159 100328 100375 100378 100473 100700 100703 100709 100710 100711 100712 100713 100717 100720 100162 85003 85004 85010 85012 85013 85014 85015 85016 85017 85018 85019 85020 85021 85022 85023 85024 85025 85026 85027 85028 85029 85030 85031 85032 85033 85034 85035 85036 85037 85038 85039 85040 85041 85042 85043 85044 85045 85046 85047 85048 85049 85050 85051 85052 85053 85054 85055 85056 85057 85058 85059 85060 85061 85062 85063 85064 85065 85066 85067 85068 85069 85070 100016 100018 100019 100022 100024 100025 100037 100038 100040 100044 100048 100049 100050 100051 100053 100054 100058 100062 100064 100065 100070 100072 100082 100084 100091 100093 100094 100099 100101 100103 100111 100113 100114 100115 100119 100122 100125 100131 100133 100134 100135 100140 100144 100149 100153 100161 100165 100169 100170 100178 100180 100181 100184 100185 100190 100191 100192 100193 100195 100200 100214 100215 100217 100221 100222 100228 100231 100236 100243 100244 100247 100260 100270 100271 100273 100274 100278 100280 100281 100289 100299 100302 100304 100308 100309 100310 100314 100318 100325 100329 100331 100335 100343 100346 100350 100351 100356 100360 100365 100368 100370 100372 100373 100374 100393 100396 100398 100399 100400 100402 100405 100406 100408 100411 100416 100423 100436 100441 100446 100449 100450 100452 100453 100454 100458 100461 100462 100463 100464 100465 100466 100469 100472 100483 100490 100491 100493 100494 100498 100503 100506 100507 100508 100509 100511 100512 100513 100517 100518 100520 100521 100522 100600 100601 100602 100603 100604 100605 100606 100607 100608 100609 100610 100611 100612 100613 100614 100615 100616 100617 100618 100619 100620 100621 100622 100623 100624 100625 100626 100627 100628 100629 100630 100631 100632 100633 100634 100635 100636 100637 100638 100639 100640 100641 100642 100643 100644 100645 100646 100647 100648 100649 100650 100651 100652 100653 100654 100655 100656 100657 100658 100659 100660 100661 100662 100663 100664 100665 100666 100667 100668 100669 100670 100671 100672 100673 100674 100675 100676 100677 100678 100679 100680 100681 100682 100683 100684 100685 100686 100687 100688 100689 100690 100691 100692 100693 100696 100697 100698 100699 100701 100702 100704 100705 100706 100707 100708 200004 200005 200098
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • 제품 설명
    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
  • 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