Events

Device Recall Samsung GU60A system Digital Xray Imaging Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NeuroLogica Corporation 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
    77384
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3036-2017
  • 사례 시작날짜
    2017-05-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155900
  • 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, stationary - Product Code KPR
  • 원인
    When performing the stitching function on gu60a system, unintended area is exposed to radiation.
  • 조치
    Neurologica will bring defect into compliance : 1.All facilities were notified via a customer notification letter. 2.Samsung will release improved software to avoid unintended exposure. When setting the stitching area, if there is an over exposed area, the height of the swivel arm will be lowered over the exposed area and the first region (first image) will be collimated by the bottom blade. 3.A software patch was developed: SW3.01 was released on 05/08/2017 and SW1.00 was released on 07/28/17. 4.The software patch will be installed on the affected devices. 5.Samsung has provided the statement and assurance that all corrections will be performed free of charge. 6.All units will be provided with updated software by November 11, 2017. For further questions, please call (978) 564-8500.

Device

Device Recall Samsung GU60A system Digital Xray Imaging Systems
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: S03PM3ADA00001T S03PM3ADC00001H S03PM3ADC00002J S03PM3AF200004X S03PM3AF200005N S03PM3AF200006E S03PM3AF300001K S03PM3AF300002Z S03PM3AF300007X S08HM3AF300001J S08HM3AF300002B S08HM3AF300004H S08HM3EF400001W S08HM3EF400002A S08HM3DF400002Y S08HM3EF400003H S08HM3EF400004K S08HM3DF400003R S08HM3DF400004B S08HM3EF400005E S08HM3DF500001B S08HM3CF500001T S08HM3EF500001K S08HM3DF500002F S08HM3BF500001L S08HM3BF500002N S08HM3CF600001R S08HM3CF600003V S08HM3DF600002P S08HM3DF600001H S08HM3DF600003L S08HM3DF600004F S08HM3DF600005Y S08HM3DF600006W 508UM3BF700001L S08HM3AFB00001Y 508UM3BG100002K 508UM3BG100001T 50FFM3AG200001V 50FFM3AG200002K 50FFM3AG200003P 50FFM3AG200004E 50FFM3AG200005J 50FFM3AG300001X 50FFM3BG600003E 50FFM3BG600002V 50FFM3BG600001A 50FFM3CG700004E 50FFM3CG700002B 50FFM3CG700003M 50FFM3CG700001P 50FFM3CG700006T 50FFM3CG700007J 50FFM3CG700005A 50FFM3CG700008N 50FFM3AG700002L 50FFM3AG700001Y 50FFM3AG800004K
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Samsung GU60A system- || Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
  • Manufacturer
    NeuroLogica Corporation

Manufacturer

NeuroLogica Corporation
  • 제조사 주소
    NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
  • 제조사 모회사 (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA