Events

Ablatherm Integrated Imaging device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edap Technomed 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
    78092
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0049-2018
  • 사례 시작날짜
    2017-08-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158643
  • 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
    High intensity ultrasound system for prostate tissue ablation - Product Code PLP
  • 원인
    The us fda has requested the optional energy treatment settings, "medium" and "low" (software protocols 02-medium and 03-low) be removed from all ablatherm integrated imagining devices in the u.S. until supporting clinical data can be submitted and evaluated by fda.
  • 조치
    The firm, EDAP TMS, company contacted all affected customers by phone during the week of August 14, 2017 and followed up with an " URGENT FIELD SAFETY NOTICE" letter dated 8/22/2017 delivered by email on 08/29/2016. The letter described the product, problem and actions to be taken. The customers were instructed as follows: do not use the "medium" or "low" energy treatment power settings in the meantime.The devices will be serviced at the consignee to remove Protocols "02-medium" and "03-low". If you have any questions regarding this notification, or experience any issues with your device, please contact EDAP TMS Customer Care Center at (512) 852-9685 or via email at service@edap-usa.com at any time, 24 hours a day, 7 days a week.

Device

Ablatherm Integrated Imaging device
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: NY, FL CA, NC, TX and NJ.
  • 제품 설명
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation || Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
  • Manufacturer
    Edap Technomed Inc.

Manufacturer

Edap Technomed Inc.
  • 제조사 주소
    Edap Technomed Inc., 5321 Industrial Oaks Blvd Ste 110, Austin TX 78735-8823
  • 제조사 모회사 (2017)
    EDAP TMS SA
  • Source
    USFDA