Events

Virtual Imaging RadPRO 40 kW 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Virtual Imaging, 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
    69388
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1064-2015
  • 사례 시작날짜
    2014-09-22
  • 사례 출판 날짜
    2015-02-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130399
  • 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, mobile - Product Code IZL
  • 원인
    There is a potential for unintended and erratic motion.
  • 조치
    Virtual Imaging sent an FIELD CORRECTION NOTIFICATION letter dated September 22, 2014, to all affected customers. The letters advised direct accounts that a Virtual Imaging Field Engineer with contact them to schedule an appointment for the replacement of the Digital Motion Control Kit. Customers with any concerns about this situation can contact Virtual Imaging's Technical Support at 561-893-8500 or via e-mail at technicalsupport@vifla.com.

Device

Virtual Imaging RadPRO 40 kW
  • 모델명 / 제조번호(시리얼번호)
    1) Model: MOBILE 32KW ANALOG; Serial Numbers: G29393 , G29395 , G29404 , G30236 , G30258 , G33309 , G33344 , G38069 , G38082 , G38711 , G38712 , G40196 , G40590 , G40989 , G41143 , G41163 , G60166 , G60169 , G60461 , G62020;  2) Model: MOBILE 40KW; Serial Numbers: G33126 , G35630 , G35641 , G35718 , G37357 , G31259;  3) Model: MOBILE 40KW 50G; Serial Numbers: G30684;  4) Model: MOBILE 40KW 55C; Serial Numbers: G37528;  5) Model: MOBILE 40KW 70C; Serial Numbers: G36211 , G36227 , G36281 , G36573 , G36581 , G36626 , G37168 , G38613 , G39518 , G40190 , G40227 , G60432 , G60435 , G60518 , G61367 , G61368 , G61720 , G61725 , G61726;  6) Model: MOBILE 40KW ANALOG; Serial Numbers: G30240;  7) Model: MOBILE2 40KW 50C; Serial Numbers: G31414 , G32487;  8) Model: MOBILE2 40KW 50G; Serial Numbers: G29416 , G29426 , G29824 , G29873 , G29878 , G30025 , G30155 , G30156 , G30160 , G30165 , G30173 , G30570 , G30685 , G30689 , G30761 , G30762 , G30767 , G30808 , G30952 , G31065 , G31067 , G31077 , G31403 , G31761 , G32577 , G32587 , G33004 , G33144 , G33581 , G33723 , G35450 , G35620;  9) Model: MOBILE2 40KW 55C; Serial Numbers: G32753 , G32764 , G33102 , G33111 , G33721 , G35462 , G35480;  10) Model: MOBILE2 40KW 55C/60C; Serial Numbers: G33585 , G37536;  11) Model: MOBILE2 40KW 55G; Serial Numbers: G32584 , G32949 , G33103 , G33127 , G33591 , G33646 , G33657 , G35422 , G35504;  12) Model: MOBILE2 40KW 55G/60G; Serial Numbers: G33711;  13) Model: MOBILE3 40KW; Serial Numbers: G41234 , G36566 , G38272;  14) Model: MOBILE3 40KW 55C; Serial Numbers: G37494 , G37501 , G37508 , G37587;  15) Model: MOBILE3 40KW 55C/60C; Serial Numbers: G35611 , G37490 , G37528 , G37588;  16) Model: MOBILE3 40KW 70C; Serial Numbers: 60597 , G36137 , G36148 , G36206 , G36217 , G36222 , G36244 , G36272 , G36287 , G36468 , G36492 , G36526 , G36537 , G36542 , G36601 , G36643 , G36681 , G36689 , G36732 , G36751 , G36761 , G37108 , G37111 , G37119 , G37129 , G37155 , G37158 , G37188 , G37196 , G37209 , G37234 , G37239 , G37293 , G37359 , G37413 , G37422 , G37430 , G37442 , G37442 , G37456 , G37466 , G37475 , G38058 , G38076 , G38173 , G38178 , G38190 , G38198 , G38279 , G38292 , G38293 , G38385 , G38391 , G38629 , G38635 , G38652 , G38657 , G39465 , G39467 , G39533 , G39551 , G39588 , G39589 , G39639 , G39650 , G39657 , G39782 , G39791 , G39800 , G39801 , G39808 , G39809 , G39818 , G40016 , G40024 , G40025 , G40116 , G40120 , G40124 , G40126 , G40185 , G40186 , G40199 , G40203 , G40211 , G40227 , G41058 , G41066 , G41083 , G41098 , G41098 , G41100 , G41104 , G41108 , G41109 , G41114 , G41119 , G41192 , G41203 , G41213 , G41218 , G41222 , G41244 , G41245 , G41256 , G60058 , G60061 , G60062 , G60063 , G60064 , G60065 , G60066 , G60069 , G-60069 , G60070 , G60406 , G60415 , G60418 , G60429 , G60430 , G60431 , G60520 , G60576 , G60577 , G60582 , G60606 , G60631 , G60635 , G60652 , G61307 , G61311 , G61333 , G61337 , G61339 , G61356 , G61393 , G61394 , G61698 , G61706 , G61715 , G61716 , G61786 , G61795 , G61812 , G61814 , G61818 , G61867 , G61872 , G61873 , G61880 , G62011 , G62012 , G62015 , G62029 , G62030 , G62037 , G62037 , G62053 , G62059 , G62062 , G62066 , G36042 , G37280 , G60400;  1)7 Model: MOBILE3 40KW 80C; Serial Numbers: G38060 , G39822 , G60067 , G61702;  18) Model: MOBILE3 40KW W/501C; Serial Numbers: G38666;  19) Model: RADPRO MOBILE; Serial Numbers: G29864 , G30250 , G30254 , G30567 , G30771 , G30902 , G30960 , G31252 , G31256 , G31271 , G31285 , G31287 , G31412 , G31480 , G31526 , G32218 , G32498 , G32514 , G32572 , G32581 , G32657 , G32671 , G33004 , G33103 , G33112 , G33126 , G33212 , G33238 , G33309 , G33324 , G33329 , G33333 , G-33634 , G33708 . G35389 , G35422 , G-35429 , G35430 , G35442 , G35524 , G35665
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the country of Canada.
  • 제품 설명
    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
  • Manufacturer
    Virtual Imaging, Inc.

Manufacturer

Virtual Imaging, Inc.
  • 제조사 주소
    Virtual Imaging, Inc., 5600 Broken Sound Blvd., 2nd Flr., Boca Raton FL 33487
  • 제조사 모회사 (2017)
    Canon Inc
  • Source
    USFDA