Events

Device Recall Spacelabs Healthcare Pathfinder SL 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
    61913
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1831-2012
  • 사례 시작날짜
    2012-05-11
  • 사례 출판 날짜
    2012-06-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109425
  • 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
    The firm received reports of the pathfinder ls software crashing after editing a batch of holter analyzer records. the software will stop with an error message requiring a restart. in addition, qtc values will not update after moving the marker.
  • 조치
    Spacelabs Healthcare, Llc sent a "MEDICAL DEVICE CORRECTION" letter dated May 11, 2012 via mailed, return receipt requested, to US customers. The customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. The letter identified the affected product, problem and actions to be taken. Consignees are advised to turn the power off and then on to restore normal functionality. Updated software will be provided upon completion of validation. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 3 for Technical Support.

Device

Device Recall Spacelabs Healthcare Pathfinder SL Holter Analyzer
  • 모델명 / 제조번호(시리얼번호)
    Version 1.6.0.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.
  • 제품 설명
    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. || Product Usage: || The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
  • 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