Events

Device Recall Pathfinder Holter Analyzer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs 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
    59004
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2611-2011
  • 사례 시작날짜
    2011-05-24
  • 사례 출판 날짜
    2011-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100815
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • 원인
    A potential hazard associated with the use of spacelabs healthcare pathfinder holter analyzer software. the second 24 hours of a 48 hours evo recording will not be analyzed.
  • 조치
    Spacelabs Healthcare sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 3, 2011 to all customers. The letter describes the product, problem, and the actions to be taken by the customers. Spacelabs Healthcare recommended that until software upgrades can be done, the customers should weigh the benefits versus the risks when deciding whether or not to continue using the product. Spacelabs Healthcare also recommended that customers advise their staff that the second 24 hours of a 48 hour EVO recording would not be analyzed. Field service engineers will be contacting customers to set up a time and date to install the revised version of the Pathfinder software. Spacelabs will upgrade Pathfinder software regardless of whether the consignees are using EVO recorders to ensure this hazard does not happen in the future. Consignees can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the US, 44 1992 507740 for any questions about this recall.

Device

Device Recall Pathfinder Holter Analyzer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: PATH-6020, PATH-6412, PATH-9072, PATH-12569, PATH-33320, PATH-33331, PATH-006005, PATH-006043, PATH-006175, PATH-006302, PATH-006314, PATH-006317, PATH-006319, PATH-006332, PATH-006333, PATH-006350, PATH-006351, PATH-006447, PATH-006448, PATH-006449, PATH-006450, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006502, PATH-006505, PATH-006506, PATH-006527, PATH-006528, PATH-006531, PATH-006537, PATH-006538, PATH-006542, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006609, PATH-006610, PATH-006612, PATH-006613, PATH-006630, PATH-006631, PATH-006632, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006712, PATH-006735, PATH-006736, PATH-006738, PATH-006831, PATH-006839, PATH-006858, and PATH-006861.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including states of CA and NC and countries of Czech Republic, Denmark, Hong Kong, Israel, The Netherlands, and United Kingdom.
  • 제품 설명
    Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. || The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America: 800-522-7025***www.spacelabshealthcare.com***". || The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both a automatic mode (tape analyzed without operator intervention) and in an interactive mode; (operator can intervene and affect analysis).
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA