Events

Corometrics Qwik Connect Plus Spiral Electrode 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
    63481
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0330-2013
  • 사례 시작날짜
    2012-10-16
  • 사례 출판 날짜
    2012-11-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113969
  • 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
    Electrode, circular (spiral), scalp and applicator - Product Code HGP
  • 원인
    Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
  • 조치
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on October 16, 2012 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: DO NOT use Qwik Connect Plus Spiral Electrodes part number 7000AAO with lot number S03123 or product with missing lot numbers; isolate all affected product; complete and return the Urgent Medical Device Correction Confirmation form via fax at 800-535-7923, return form even if no recall product is in inventory; to return only unused product, and if they have forwarded any affected lot numbers of this product to any other healthcare institutions, forward a copy of this letter to those institutions. If you have any questions or concerns regarding this notification, 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

Corometrics Qwik Connect Plus Spiral Electrode
  • 모델명 / 제조번호(시리얼번호)
    Lot #S03123 Model #7000AA0
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
  • 제품 설명
    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 || A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
  • 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