Events

Device Recall Natus neoBLUE 2 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
    69820
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0847-2015
  • 사례 시작날짜
    2014-11-19
  • 사례 출판 날짜
    2014-12-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131593
  • 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
    Neonatal phototherapy unit - Product Code LBI
  • 원인
    Replacement led board kit of natus neoblue2 phototherapy system distributed after february 16, 2012 is subject of a field safety notification because the system will exhibit a higher light intensity output than the original device. while some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
  • 조치
    Natus Medical has begun mailing the Urgent Recall Notification/Field Safety Notice neoBLUE LED Board Replacements letter (DOC-012737B), dated November 5, 2014, to US consignees. Natus Medical also send the Product Advisory neoBLUE LED Board Replacements letter (DOC-0012738), dated October 30, 2014, to International Distribution Partners. Both US and International consignees also received the TECHNICAL BULLETIN LED Board Kit, neoBLUE 2 LED Phototherapy System, p/n: 001840, Treatment Intensity with revised LED board for neoBLUE 2 systems (p/n: 040904 & 040906) [DOC 008353]; and the Label, neoBLUE Intensity/Height (DOC 011561). Consignees are instructed to measure the light intensity of their devices and to document that information of the device using an adhesive label that is provided. The neoBLUE 3 system and its replacement panel sold today are not affected by this issue. If there are any questions regarding this advisory letter or the attached Technical Bulletin, please call Natus Technical Service at 888-496-2887.

Device

Device Recall Natus neoBLUE 2 Phototherapy system
  • 모델명 / 제조번호(시리얼번호)
    All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    worldwide
  • 제품 설명
    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
  • 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