Events

Device Recall Natus neoBLUE blanket 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
    70810
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1412-2015
  • 사례 시작날짜
    2015-03-16
  • 사례 출판 날짜
    2015-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134774
  • 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
    Neoblue blanket led phototherapy system is recalled because natus has received feedback from some customers about early failure of the neoblue blanket system fiberoptic pads. these failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoblue blanket light box.
  • 조치
    Natus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. Natus emailed the Distribution Partner (DP) letter to all Natus International Distribution Partners, requiring that they notify their customers (at Biomedical Department and Neonatal Intensive Care Unit) with copies of the Field Safety Notice, customer letter, the Technical Bulletin, Instructions for Use, and Service Manual. The technical bulletin asks the customer to visually and tactilely inspect the fiber optic cable connector before use, and to call Natus if they notice a failing pad. This procedure will prevent the complete degradation and therapy will not be compromised. U.S. customers should contact Natus Technical Service at 888-496-2887 with any questions regarding this notification. International customers should contact their local distributors or contact Natus Technical Service at (888) 496-2887 or Technical_Service@natus.com.

Device

Device Recall Natus neoBLUE blanket LED Phototherapy system
  • 모델명 / 제조번호(시리얼번호)
    None
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    distributed worldwide
  • 제품 설명
    Natus neoBLUE blanket LED Phototherapy system which includes the following items: || 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad || 006254 neoBLUE blanket LED Light Box || 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad || 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR || 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR || 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK || 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK || 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS || 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
  • 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