Events

Device Recall Artis zee floor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    77908
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3095-2017
  • 사례 시작날짜
    2016-02-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158187
  • 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, angiographic - Product Code IZI
  • 원인
    Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. loss of coolant can results in a cooling system failure and subsequent system failure. this leek can occur sporadically in affected systems.
  • 조치
    Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 18, 2016, to affected customers informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an appointment to schedule the work For questions regarding this recall call 610-.448-6461.

Device

Device Recall Artis zee floor
  • 모델명 / 제조번호(시리얼번호)
    Artis zee floor- Serial number: 137623 137165 137282 137618 137226 136513 136562 137118 137103 137461 137510 137193 137479 137425 137540 137532 137314 137295 137582 137592 136568 137075 137130 137188 137131 137146 136607 136579 137388 137470 124007 124015 137347 137638 137389 137595 137245 137620 137335 137617 137607 136500 136515 137369 137569 136479 137119 124051 136488 136550 136450 136408 136547 136508 136517 124039 137360 137311 137320 136586 136520 137521 137639 136548 137645 137395 137093 137018 136483 136555 137421 137551 137471 137591 137239 137438 136614 137384 137011 136567 124034 137403 137391 137296 137458 136970 137229 137112 136561 136505 124006 137244 137231 137219 137513 137224 137217 136979 137329 137328 136557 136558 137511 136503 137297 136582 136570 137567 136459 136518 136609 136594 124056 137579 137218 137518
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic || AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA