Events

Device Recall Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    76805
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1779-2017
  • 사례 시작날짜
    2017-03-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-03-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154231
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    Ge healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. there have been no injuries reported because of this issue.
  • 조치
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 76164,76168 dated March 10, 2017. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering, & Managers of Radiology / Managers of Cardiology. The letter described the safety Issue, Safety Instructions, Affected Product Detail, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
  • 모델명 / 제조번호(시리얼번호)
    Mfg. Lot or Serial # System ID 1 VE95R00100 AU00104 VE95R00104 AU00107 VE95R00107 AU00109 VE95R000109 AU00110 VE95R000110 AU00111 VE95R000111 AU00113 VE95R000113 AU00117 VE95R000117 AU00118 VE95R000118 AU00120 VE95000120 AU00121 VE95R000121 AU00123 VE95R000123 AU00124 VE95R000124 AU00125 VE95R000125 AU00126 VE90000126 AU00127 VE95R000127 AU00128 VE95R000128 AU00132 VE90000132 AU00133 VE95R000133 AU00135 VE90000135 AU00138 VE95R000138 AU00159 VE95R000159 AU00160 VE9500160 AU00162 VE95000162 AU00165 VE95000165 AU00168 VE95000168 AU00171 VE90000171 AU00172 VE95R000172 AU00173 VE90000173 AU00174 VE90000174 AU00176 VE95000176 AU00182 VE95000182 AU00183 VE90000183 AU00184 VE95R000184 AU00206 VE9500206 AU00207 VE95U00207 AU00211 VE9500211 AU00224 VE90000224 AU00230 VE95000230 AU00231 VE90000231 AU00232 VE90000232 AU00240 VE95R000240 AU00242 VE95000242 AU00243 VE90000243 AU00246 VE95V000246 AU00258 VE90000258 AU00277 VE95R000277 AU00281 VE95000281 AU00287 VE95000287 AU00300 VE95000300 AU00302 VE95R000302 AU00321 VE9500321 AU00329 VE95000329 AU00330 VE95000330 AU00331 VE9500331 AU00332 VE95000332 AU00335 VE95R000335 AU00339 VE9500339 AU00347 VE95000347 AU00348 VE95000348 AU00352 VE95000352 AU00359 VE9500359 AU00360 VE95000360 AU00361 VE95000361 AU00363 VE95000363 AU00367 VE95000367 AU00368 VE95000368 AU00369 VE95000369 AU00370 VE95000370 AU00372 VE95000372 AU00373 VE95000373 AU00374 VE9500374 AU00376 VE95R00376 AU00388 VE95000388 AU00396 VE95000396 AU00398 VE95000398 AU00401 VE95000401 AU00407 VE95R000407 AU00417 VE95000417 AU00426 VE95000426 AU00429 VE95000429 AU00430 VE95000430 AU00434 VE95000434 AU00438 VE9500438 AU00439 VE95000439 AU00441 VE95000441 AU00446 VE90000446 AU00448 VE95000448 AU00450 VE9500450 AU00454 VE95000454 AU00457 VE95000457 AU00460 VE95000460 AU00465 VE95000465 AU00466 VE95000466 AU00468 VE95000468 AU00474 VE95000474 AU00478 VE95000478 AU00482 VE95000482 AU00486 VE95000486 AU00488 VE90000488 AU00494 VE95000494 AU00499 VE95000499 AU00501 VE90000501 AU00505 VE95000505 AU00509 VE95000509 AU00512 VE95000512 AU00517 VE90000517 AU00521 VE90000521 AU00527 VE95000527 AU00531 VE9500531 AU00532 VE95000532 AU00550 VE95000550 AU00551 VE90000551 AU00552 VE95000552 AU00554 VE95000554 AU00565 VE95000565 AU00568 VE90000568 AU00571 VE9500571 AU00574 VE95000574 AU00575 VE95000575 AU00577 VE95000577 AU00580 VE95000580 AU00581 VE95000581 AU00582 VE90000582 AU00586 VE95000586 AU00590 VE95000590 AU00592 VE95000592 AU00593 VE90000593 AU00595 VE95000595 AU00598 VE95000598 AU00601 VE90000601 AU00602 VE95000602 AU00605 VE90000605 AU00608 VE9500608 AU00610 VE90000610 AU00616 VE90000616 AU00618 VE9500618 AU00621 VE95000621 AU00624 VE95000624 AU00625 VE95000625 AU00628 VE9000628 AU00630 VE95000630 AU00633 VE95000633 AU00661 VE95000661 AU00667 VE90000667 AU00684 VE95000684 AU00685 VE95R000685 AU00694 VE90000694 AU00700 VE95000700 AU00707 VE95000707 AU00714 VE95000714 AU00720 VE95000720 AU00722 VE95000722 AU00728 VE95000728 AU00733 VE95000733 AU00734 VE95000734 AU00736 VE95000736 AU00744 VE90000744 AU00747 VE95000747 AU00757 VE95000757 AU00761 VE95000761 AU00762 VE95000762 AU00767 VE95000767 AU00768 VE95000768 AU00769 VE90000769 AU00770 VE95000770 AU00773 VE95000773 AU00775 VE95000775 AU00779 VE95000779 AU00780 VE95000780 AU00783 VE95000783 AU00784 VE95000784 AU00789 VE95000789 AU00795 VE90000795 AU00808 VE90000808 AU00817 VE95000817 AU00820 VE95000820 AU00821 VE95000821 AU00836 VE95000836 AU00838 VE90000838 AU00849 VE90000849 AU00852 VE95000852 AU00853 VE90000853 AU00858 VE95000858 AU00862 VE95000862 AU00863 VE95000863 AU00864 VE95000864 AU00865 VE95000865 AU00866 VE95000866 AU00872 VE95000872 AU00873 VE95000873 AU00875 VE95000875 AU00878 VE95000878 AU00884 VE95000884 AU00888 VE95000888 AU00895 VE95000895 AU00913 VE95000913 AU00924 VE95000924 AU00942 VE95R000942 AU00944 VE95000944 AU00950 VE95000950 AU00952 VE95000952 AU00953 VE95000953 AU00959 VE95R000959 AU00965 VE95000965 AU00970 VE95000970 AU00972 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia, Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria, Australia, Argentina, Vietnam. Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan, Indonesia, Guadeloupe, Czech Republic
  • 제품 설명
    Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA