Events

Device Recall IQecg 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Brentwood Medical Technology Corp 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
    56016
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2724-2011
  • 사례 시작날짜
    2010-05-18
  • 사례 출판 날짜
    2011-07-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92429
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • 원인
    The recall was initiated because when a user of the iqmanager, iqdevices sdk, and iqic (centricity) software versions listed above accesses the qt dialogue box to either accept or edit the qt value, the qtc value is recalculated using a hodges qtc equation, regardless of patient's age. the software does this without notifying the user of the change from use of the bazett equation, which is utiliz.
  • 조치
    The firm, Midmark, sent an "URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter on May 19, 2010 with an attached Corrective Return Material Authorization (RMA) form via US Postal Service Certified Mail to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their IQecg, IQmanager, or lQiC Centricity software to determine the software version currently in use. If it is a listed product, it is subject to this field corrective action. A sample software label was attached to aid the consignees/customers in locating and identifying the software CD. For customers who have already installed the software, the version number can be identified in the "About" page. Consignees/customers were instructed to complete the enclosed Field RMA form and return it with the affected software to: Quality Assurance Department Midmark Diagnostics Group 1125 West 190 S t. Gardena, CA 90248 In addition, if they further distributed this product, identify customers and notify them at once of this product field corrective action. Replacement software was to be shipped to the consignees/customers upon receipt of the returned software CD. If they require a UPS return shipping label or an on-line download of replacement software, contact Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or 5108. If you have any questions, call Midmark Diagnostics Group Support Services at 800-624-8950 extension 5145 or QA/RA Manager, Midmark Diagnostics Group 310-516-5116.

Device

Device Recall IQecg
  • 모델명 / 제조번호(시리얼번호)
    Software Version 6.0
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of: Algeria, Australia, Canada, France and Saudi Arabia.
  • 제품 설명
    IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 || IQecg is to be used, under the supervision of a Physician, to obtain Electrocardiograms from the human body surface.
  • Manufacturer
    Brentwood Medical Technology Corp

Manufacturer

Brentwood Medical Technology Corp
  • 제조사 주소
    Brentwood Medical Technology Corp, 1125 W 190th St, Gardena CA 90248-4303
  • 제조사 모회사 (2017)
    Midmark Corporation
  • Source
    USFDA