Events

Siemens Uroskop Omnia Max system 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
    69258
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0004-2015
  • 사례 시작날짜
    2014-09-02
  • 사례 출판 날짜
    2014-10-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130371
  • 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, fluoroscopic, image-intensified - Product Code KPR
  • 원인
    Two malfunctions posing potential risk to patients were identified with siemens ysio max, axiom luminos drf max, uroskop omnia max, and luminos agile max systems with a specific set of serial numbers that will cause lost images due to an automatic radiology information system (ris) worklist update, thus causing examinations to be repeated. image label may also be displayed incorrectly after images.
  • 조치
    Siemens sent a Safety Advisory Notice, dated September 2, 2014, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disable the automatic RIS worklist update and perform this procedure manually. Customers should disable the Measurement Field Display and Collimator Display by setting the display time for both setting to 0 sec (if editable). Customers should forward the safety notice to the new owner and inform Siemens of the new owner where possible. Customers with questions should call 610-219-2119 or 610-219-4834. For questions regarding this recall call 610-219-6300.

Device

Siemens Uroskop Omnia Max system
  • 모델명 / 제조번호(시리얼번호)
    Siemens Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
  • 제품 설명
    Siemens Uroskop Omnia Max system || The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA