Events

Device Recall General Purpose Temperature Probe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Signs Devices, a GE Healthcare Company 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
    65857
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1959-2013
  • 사례 시작날짜
    2013-07-18
  • 사례 출판 날짜
    2013-08-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120513
  • 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
    Thermometer, electronic, clinical - Product Code FLL
  • 원인
    Ge healthcare has become aware of a potential safety issue associated with the use of ge general purpose 9 french temperature probe, disposable, 400 series [m1024229]. ges disposable general purpose 9fr temperature probe m1024229 is intended for oro-esophageal and rectal use. as it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe.
  • 조치
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 23, 2013 via Fed Ex beginning on July 29, 2013 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE will update the Instructions for Use (IFU) and pouch label with new content related to insertion locations. GE has will also place the probe (M1024229) on quality hold until the new labeling changes are implemented. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at 1-800-588-7044 (Domestic) or Vital Signs Customer Service at 1-800-932-0760 (international). Hours of operation: 8:00 am EST to 6:00 pm EST.

Device

Device Recall General Purpose Temperature Probe
  • 모델명 / 제조번호(시리얼번호)
    GE product number M1024229
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.
  • 제품 설명
    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. || Continuous temperature monitoring.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • 제조사 주소
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA