Events

Device Recall Dual 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
    61807
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1945-2012
  • 사례 시작날짜
    2012-05-01
  • 사례 출판 날짜
    2012-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109139
  • 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
    There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
  • 조치
    Atom Medical sent an Urgent Field Safety Notice dated May 1, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify all affected product in their inventory and quarantine them until the rework was complete. Customers were also asked to identify any customers to whom they further distributed the product and to contact their customers at once and arrange a time in whcih the filed service technician could perform the rework. Customers were asked to return the Recall Response Forms to Atom Medical (kirautc@atomed.co.jp, tsugino@atomed.co.jp, or matsumoto@atomami.co.jp). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.

Device

Device Recall Dual Incu i
  • 모델명 / 제조번호(시리얼번호)
    All lots on the market of model 100
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands
  • 제품 설명
    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
  • Manufacturer
    Atom Medical Corporation

Manufacturer

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