Events

Device Recall 3T 16ch FlexSPEEDER Coil 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NeoCoil, LLC 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
    74477
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2312-2016
  • 사례 시작날짜
    2016-06-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147742
  • 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
    Coil, magnetic resonance, specialty - Product Code MOS
  • 원인
    There is a potential for higher than specified surface temperatures involving the 3t 16ch flex speeder large coil.
  • 조치
    NeoCoil sent an "Urgent Medical Device Recall" letter dated 17 June 2016. The letter described the problem and the product involved in the recall. Advised consignee to quarantine the product and if the product was further distributed to identify the customers and provide the list to NeoCoil. The recall will be carried to the user level. Requested consignee to complete and return the response form. For questions call 262-522-6127.

Device

Device Recall 3T 16ch FlexSPEEDER Coil
  • 모델명 / 제조번호(시리얼번호)
    "Neocoil  serial Number"  046-4-0012 046-4-0013 046-4-0014 046-4-0015 046-4-0016 046-4-0017 046-4-0018 046-4-0019 046-4-0020 046-4-0021 046-4-0022 046-4-0023 046-4-0024 046-4-0025 046-4-0026 046-4-0027 046-4-0028 046-4-0029 046-4-0030 046-4-0031 046-4-0032 046-4-0033 046-4-0034 046-4-0035 046-4-0036 046-4-0037 046-4-0038 046-4-0039 046-4-0040 046-4-0041 046-4-0042 046-4-0043 046-4-0044 046-4-0045 046-4-0046 046-4-0047 046-4-0048 046-4-0049 046-4-0050
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
  • 제품 설명
    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. || To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
  • Manufacturer
    NeoCoil, LLC

Manufacturer

NeoCoil, LLC
  • 제조사 주소
    NeoCoil, LLC, N27W23910 Paul Rd Ste A, Pewaukee WI 53072-6204
  • 제조사 모회사 (2017)
    Neocoil Llc
  • Source
    USFDA