Events

VITALTEMP General Purpose Probe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Signs Colorado Inc. 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
    63532
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0407-2013
  • 사례 시작날짜
    2012-08-17
  • 사례 출판 날짜
    2012-11-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114152
  • 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
    Probe, ent - Product Code KAK
  • 원인
    There is a potential for epistaxis during use of the disposable general purpose 9 french temperature probe.
  • 조치
    The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and Confirmation form on August 17, 2012 via Fed Ex to its consignees/customers. The letter describes the product, problem and action to be taken. The customers were instructed to do the following: Do not use the Disposable General Purpose 9 French Temperature Probe P/N 1016 or 1016EU; return all unopened product(s) to Vital Signs Devices (VSD) 11039 East Lansing Circle, Englewood, CO 80112-note: replacements and/or refunds discussed in letter are available only in exchange for the return of any unopened product(s); complete and return the URGENT MEDICAL DEVICE CORRECTION CONFIRMATION via fax to: 800-535-7923; forward a copy of the letter to any institutions they may have forwarded the product and for customers using the GXXXXX64 kit that includes the Disposable General Purpose 9 French Temperature Probe follow the directions listed in the letter. Note: VSD is removing p/n 1016 and 1016EU, Disposable General Purpose 9 French Temperature Probe, from the market and offering a replacement. If you have any questions or concerns regarding this notification, contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation 8:00 am EST to 6:00 pm EST.

Device

VITALTEMP General Purpose Probe
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers 1016, 1016EU, R1016ES; GXXXX64 All units Made in Costa Rica are affected Lot Numbers:    12089A 12131A   5575A 5586X 5633U 5664E 5685G 5712T  12090B 12138A 5578K 5603R 5636Y 5666R 5685H  5714Z  12100A 12157B 5578L 5606U 5638P 5668N 5685J  12101B 12173A 5580Y 5614N 5638Q 5669G 5689Y  12102A 5573Q 5580Z 5615N 5648T 5669H 5691T  12108B 5574A 5581A 5621U 5648U 5671D 5692H  12109B 5574B 5581L 5623H 5653Z 5673V 5696Q  12114B 5574X 5583E 5631C 5658D 5683V 5700J  12117B 5574Y 5584C 5632V 5660C 5683W 5703N  12130B 5574Z 5584D 5633T 5664D 5683X 5708R
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.
  • 제품 설명
    Vital Signs Disposable General Purpose 9 French Temperature Probe || For monitoring of core temperature
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • 제조사 주소
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA