Device Recall Incu i 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Atom Medical Corporation 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
    59767
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0338-2012
  • 사례 시작날짜
    2011-08-23
  • 사례 출판 날짜
    2011-12-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Incubator, neonatal - Product Code FMZ
  • 원인
    The caster with lock on the incubator may become loose or break.
  • 조치
    The firm, Atom Medical, sent an "Urgent: Field Safety Notice" letter dated August 18, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all devices in their inventory and quarantine them until the rework is complete; identify any customers to whom they have further distributed the product; contact their customers at once and arrange a time in which the field service technician can perform the rework (the parts needed to complete the rework will be sent from Atom Medical's export department ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) If you have any questions, contact the Manager Quality Control or Manager, Regulatory Affairs at email addresses above, phone: +81-3-3815-3632 or fax +81-3-3812-3199.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots on the market.  model 101
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including state of: PA and countries of: Algeria, Austria, Australia, China, Egypt, Germany, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Russia, Saudi Arabia, Spain, Switzerland, Thailand, The Netherlands, and UAE.
  • 제품 설명
    Incu i (Atom Infant Incubator Model 101) || Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 || Usage: An incubator for infants.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Atom Medical Corporation, 3-18-15 Hongo, Bunkyo-Ku Japan
  • 제조사 모회사 (2017)
  • Source
    USFDA