Events

Device Recall Corometrics MODEL 250 Series Maternal/ Fetal Monitor, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datex Ohmeda, Inc. dba GE Healthcare 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
    48467
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2154-2008
  • 사례 시작날짜
    2008-05-05
  • 사례 출판 날짜
    2008-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71483
  • 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
    Perinatal Monitoring System - Product Code HGM
  • 원인
    Communication connector within monitor is defective and may cause potential loss of telemetry.
  • 조치
    The recalling firm notified healthcare professionals by an Urgent Medical Device Correction letter dated 07/01/2008 to Healthcare Administrators, Risk Managers, Nurse Managers and Directors of Clinical Engineering. The letter advised of a defect in a communication board that may cause a potential loss of telemetry monitoring. The firm recommended that the device should not be used with the firm's 340 Series telemetry system pending replacement of the defective board by service engineers. The Healthcare Professionals are asked to contact the GE Healthcare Technical Support center at 1-800-558-7044.

Device

Device Recall Corometrics MODEL 250 Series Maternal/ Fetal Monitor,
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: SBE07014189PA SBE07014184PA SBE07014167PA SBE06524133PA SBE07014196PA SBE07024243PA SBE07034259PA SBE07024238PA SBE07034256PA SBE07024218PA SBE07034268PA SBE07024212PA SBE07054323PA SBE07064333PA SBE07064354PA SBE07034248PA SBE07024229PA SBE07024211PA SBE07024239PA SBE07024237PA SBE07024203PA SBE07064387PA SBE07064335PA SBE07064395PA SBE07014187PA SBE07024225PA SBE07024227PA SBE07014181PA SBE07024204PA SBE07024206PA SBE07034313PA SBE07044317PA SBE07034261PA SBE07024231PA SBE07034276PA SBE07064357PA SBE07024219PA SBE07014194PA SBE07044315PA SBE07024201PA SBE07024215PA SBE07034302PA SBE07034252PA SBE07014179PA SBE07034247PA SBE07034246PA SBE07014152PA SBE07024244PA SBE07014191PA SBE07034298PA SBE07034299PA SBE07024241PA SBE07044322PA SBE07024216PA SBE07044318PA SBE07024213PA SBE07044316PA SBE07034260PA SBE07064375PA SBE07064398PA SBE07064368PA SBE07064377PA SBE07064373PA SBE07064341PA SBE07064384PA SBE07034255PA SBE07064347PA SBE07014185PA SBE07024208PA SBE07024214PA SBE07024205PA SBE07024207PA SBE07064389PA SBE07064330PA SBE07064352PA SBE07034250PA SBE07034257PA SBE07034254PA SBE07044321PA SBE07024242PA SBE07024235PA SBE07034270PA SBE07034264PA SBE07024220PA SBE07024236PA SBE06514069PA SBE06514079PA SBE06514078PA SBE06514081PA SBE06514092PA SBE06514084PA SBE06514090PA SBE07014199PA SBE07064385PA SBE07064390PA SBE07064393PA SBE07064331PA SBE07014200PA SBE07064369PA SBE07024232PA SBE07034296PA SBE07064340PA SBE07034307PA SBE07034309PA SBE07064353PA SBE07034301PA SBE07034310PA SBE07034300PA SBE07034306PA SBE07034308PA SBE07044319PA SBE07034312PA SBE07034304PA SBE07014166PA SBE07034272PA SBE07034281PA SBE07034290PA SBE07034291PA SBE07054324PA SBE07064329PA SBE07034280PA SBE07064334PA SBE07064336PA SBE07024240PA SBE07034251PA SBE07034267PA SBE07034293PA SBE07034279PA SBE07034274PA SBE07034258PA SBE07064345PA SBE07034286PA SBE07034295PA
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Corometrics¿ MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. || Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02.
  • Manufacturer
    Datex Ohmeda, Inc. dba GE Healthcare

Manufacturer

Datex Ohmeda, Inc. dba GE Healthcare
  • 제조사 주소
    Datex Ohmeda, Inc. dba GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA