Events

NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series CT Scanner System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips And Neusoft Medical Systems Co., Ltd. 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
    63553
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0466-2013
  • 사례 시작날짜
    2012-10-18
  • 사례 출판 날짜
    2012-12-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114197
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • 원인
    The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. this issue may affect neuviz dual and neuviz 16 scanners.
  • 조치
    Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at nms-service@neusoft.com For questions regarding this recall call 425-487-7665.

Device

NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series CT Scanner System
  • 모델명 / 제조번호(시리얼번호)
    NeuViz 16 system Serial numbers:  N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024.   Neuviz Dual Serial numbers:  400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
  • 제품 설명
    NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 || The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
  • Manufacturer
    Philips And Neusoft Medical Systems Co., Ltd.

Manufacturer

Philips And Neusoft Medical Systems Co., Ltd.
  • 제조사 주소
    Philips And Neusoft Medical Systems Co., Ltd., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA