Events

Device Recall iCAT Classic (XRay Tube head and Power Supply) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Imaging Sciences International, 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
    57583
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3018-2011
  • 사례 시작날짜
    2010-12-15
  • 사례 출판 날짜
    2011-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96704
  • 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
    Recalling firm received a customer complaint regarding a defective x-ray tube head and power supply.
  • 조치
    The firm, Imaging Sciences, sent an "Urgent Medical Device Field Correction" letter dated December 15, 2011 via first class USPS to its customer. The letter noted the product and described the problem and action to be taken. The customer was instructed to complete and return the ACKNOWLEDGEMENT FORM via fax to 215-997-5665 or email: darin.oppenheimer@imagingsciences.com. Imaging Sciences stated in the letter that an X-ray tube head and power supply will be provided and installed by one of their technicians. Should you have any questions regarding this information, call 215-622-1545.

Device

Device Recall iCAT Classic (XRay Tube head and Power Supply)
  • 모델명 / 제조번호(시리얼번호)
    Part number 9140-0035 (Tube head) and 9140-1001 (Power Supply)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169
  • 제품 설명
    i-CAT Classic (X-Ray Tube head and Power Supply) || X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.
  • Manufacturer
    Imaging Sciences International, LLC

Manufacturer

Imaging Sciences International, LLC
  • 제조사 주소
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA