Events

Natus neoBLUE LED Phototherapy system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Natus Medical Incorporated 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
    73169
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2001-2016
  • 사례 시작날짜
    2016-04-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143307
  • 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
    Unit, neonatal phototherapy - Product Code LBI
  • 원인
    The firm is adding the warning statement to the instruction for use for the neoblue led phototherapy system and provide a laminated quick guide to affix to each device.
  • 조치
    The URGENT: FIELD SAFETY NOTICE PRODUCT LABELING CHANGE neoBLUE LED Phototherapy System, dated April 2016, was went to US customers between April 11, 2016 and April 27, 2016. Natus distribution partners outside the US will receive the Letter to Distributors and they are requested to contact their downstream customers to distribute the information. The estimated date of notifying international consignees is May 31, 2016. Enclosed with this letter, customers would receive: 1) Quick Guides (2 each) which provide operating steps, information about measuring intensity, and warnings (PN 051693) 2) User manual addendum 3) Customer reply form Natus requests that this information be distributed to all associated parties within your organization that use or service this product. Please note: this communication is in addition to any prior labeling changes that you may have received from Natus. Customers should submit the Reply Form via fax to 847-949-6031 or email to mailto:Natus_Quality_Programs@natus.com. If there are any questions regarding this letter and addendum, please call Natus Technical Service at 888-496-2887.

Device

Natus neoBLUE LED Phototherapy system
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.
  • 제품 설명
    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. || Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. || Product Usage: || Used to provide treatment for neonatal hyperbilirubinemia
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • 제조사 주소
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • 제조사 모회사 (2017)
    Natus Medical Incorporated
  • Source
    USFDA