Events

Device Recall Philips OmniDiagnostClassic 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems Nederlands 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
    80271
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2301-2018
  • 사례 시작날짜
    2018-05-01
  • 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=165012
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    The fixation of the upper and lower tilt actuator, of the omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. this rotating movement can not be stopped by the user. this could potentially lead to the patient falling off the table. there is a risk of injury for the patient, user, or bystander.
  • 조치
    On May 17, 2018, the firm issued Urgent Medical Device Correction letters to affected consignees. Customers were advised of the product issue. Customers were instructed to do the following: Stop using the system and call your Philips representative if any of the following situations occurs: . the table height or tilt movement is not working. . you notice a cracking sound or snapping sound different than the normal sound during height or tilt movement. . you experience a blockade in the table height or tilt movement during system movements. . the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. . you have used a CPR stand that obstructed the system, or . you notice any (other) unusual system behavior beyond the normal use of the system. Avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. Customer shall ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. The firm plans to correct all potentially affected products in the field by means of a field change order free of charge. Customers will be contacted by a local Philips representative to schedule the corrective action, which will start effective July 2018. Customer with further questions may contact Philips Technical Support Line: 1-800-722-9377.

Device

Device Recall Philips OmniDiagnostClassic
  • 모델명 / 제조번호(시리얼번호)
    As-Maintained System Equipment Number: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86965 86340 1520 101154 1873 102164 102977 83871 83958 86113 104857 103052 103219 84850 86303 103055 103058 103218 104012 104934 104577 105324 504972 504297 104858 529688 527085 527086 527104 527090 527082 529687 527080 527087 529686 527091 527092 527089 527093 529705 527109 527088 527102 527107 527083 527084   529703 529699 529713 529706 529712  529690 529710 529709 529708 529707 14629273 15893969 35015270 35014092 35127787 34997249 15849132 15857294 158554 15841822 15858211 16231503 15831844 16409964 16802355 18055578 18560502 15857902 15858098 303148 15854028 17492237 17541021 31456486 17758213 17941166 19392346 19579758 19782801 18809817 19257910 31103760 19782331 19935548 30396410  32054303 30194039  30873909 37103066 34090526 31596158 10135906 10166050 10006064 16064 10138539 47843126 479951 47911693 47901391 47844078 47944782 48030899 478435 47891928 47912290 48005677 486819 47837945 484516 47884920 47859977 47923515 48059776 48050512 47884354 47850684 48149946 47872003 47938350 47943336 47898047 48060837 478948 50194622 48016151 48062720 47995620 479809 47999720 47844799 47900809 48017211 47882644 47908199 48020563 48026144 48030684 47890048 48055971 47894387 47943186 47937552 48062279 47884829 47872447 47937672 48078137 47913036 479468 47894218 47926963 47889912 47900468 479897 47893535 47893638 47989775 48025019 48066707 48076135 47905960 14430237 48036987 48034012 48018140 47845684 47924690 15314079 47871520 47947079 48023192 47867463 47942597 486893 48016769 47987041 47871768 47934458 47987152 48037814 48055063 48055336 47989269 47945064 47847747 48025542 47902864 47883970 47880733 48022528 48056372 48056424 48056474 47880372 47954220 47843577 47878837 47951539 48048118 47956370 48008155 47915670 47838516 47921591 48057153 48086181 47840577 483428 47937095 47846955 47897860 48019597 48078998 47994839 48019837 47932196 47889837 48055440 47876560 47937175 47994577     47840758 47835296 47918167 48044073 47903895 48053656 485677 47902524 47894944 47922669 55780435 48027852 47896589 48023262 48015942 481403 47963682 48001403 47999799 48011103 48048560 47905125 47845762 479712 47900712 48173118 47999344 480515 47868786 47999900 47886317 48047270 47960473 47888204 48086244 48036906 47995001 53261099 479999 912567 47996686 47838739 488155 47902340 47981406 48027784 47843335 47888783 478723 912554 912570 912559 581026 186984 912572 912573 912564 912558 912569 912563 912561 912551 912560 912552 912574 912575 912562 912556 36920957 912568 912566 912576 912565 912577 912555 912550 912553 193444 91002561 35411240 149457 912557 912571 48155079 42612895 51040917 51029767 51047402 50937663 51028970 50988581 50976660 51103727 50901797   50969468 50978845 51020690  50968278  51072875 50997325  51112717 51069644 50977659 50994437 51029062 51029673 50964975 50951499 51040304 51112897 15868176 15867868 48152770  42679080 42680261 162624 186454    47952304 47952194 16216632 10188638 10123241 36962750 36970721 48114348 48156059 48142307 48114234 48114558 75795774 75795892 57742137 18045135 37203863 37283054 37271725 37194973 37178219 37192552 37197676 37126660 37126769 37218356  37134483     37270177 37121779 37112241 37228570 37192635 37129310 37275288 37245565 37210949 33317303 10119343 10146416 141793 15983788 14430350 15313955 15314202 34767769 34750597 49888651 34764332 34764834 47352569 34764731 34764966 54375348 36274326 36348140 36358901 36425595 36196325 36247890 36404575 36306923 36371177 36347422 362891 36321062 36334792  36287232 36384474 36396773 36209250 362623 36318737 36314659
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Healthcare facilities in AZ, CA, CO, FL, IA, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NJ, NY, OK, OR, PA, TN, TX, VA, WA, and WI.
  • 제품 설명
    OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • 제조사 주소
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA