Events

Device Recall The Medix NatalCare STLX Intensive Care Incubator 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
    74627
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0056-2017
  • 사례 시작날짜
    2016-08-25
  • 사례 출판 날짜
    2016-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148064
  • 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
    Natalcare lx incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. there were several complaints of wheels bending out of alignment.
  • 조치
    Natus sent an Urgent Notification Field Safety Notice on August 25, 2016 to all affected customers. Customers are asked to inspect the quality of the welds and wheel alignment for the Natal Care LX Incubators at their facility per attached Inspection Instructions for Assessing the Natal Care LX Wheeled-Based Joint and Weld. Customers are provided with the Natal Care LX Rolling Base Verification Form (DOC-019727) and are requested to verify the weld and gap status for each of the four wheels on the incubator and to note the results on the verification form. After the Verification form is completed and returned to Natus, Natus will arrange to ship a repair kit for each affected wheel, along with instructions and simple tools to facilitate the repair of the Natal Care LX base. Natus Technical Service will follow-up with phone calls to all non-responding customers and again to verify that the repairs have been performed. Consignees who have any questions, please call Technical Service at 888-496-2887 or send email to technical_service@natus.com

Device

Device Recall The Medix NatalCare STLX Intensive Care Incubator
  • 모델명 / 제조번호(시리얼번호)
    5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097, 5128, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138, 5139, 5209, 5210, 5211, 5212, 5213, 5214, 5219, 5220, 5221, 5222, 5223, 5224, 5225, 5226, 5227, 5228, 5248, 5249, 5250, 5251, 5252, 5253, 5254, 5255, 5256, 5257, 5276, 5277, 5278, 5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5287, 5288, 5289, 8290, 5291, 5292, 5293, 5294, 5322, 5323, 5324, 5325, 5326, 5327, 5328, 5329, 5330, 5331, 5332, 5333, 5334, 5335, 5336, 5337, 5383, 5385, 5388, 5389, 5504, 5505, 5506, 5507, 5508, 5509, 5510, 5511, 5543, 5544, 5545, 5546, 5547, 5548, 5549, 5550, 5551, and 5552.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC and VA, and Internationally to Pakistan.
  • 제품 설명
    The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. || Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
  • 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