Events

Device Recall KODAK TMAT L/RA Film 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carestream Health, Inc. 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
    54981
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1314-2010
  • 사례 시작날짜
    2010-03-12
  • 사례 출판 날짜
    2010-04-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89615
  • 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
    film, radiographic - Product Code IWZ
  • 원인
    Product mix-up. the firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be t-mat l/ra, it was performing like t-mat g/ra.
  • 조치
    A "MEDICAL DEVICE RECALL (VOLUNTARY)" letters and Response Forms (dated 3/12/10) were sent to the customers on 3/12/10 via Certified Mail, Return Receipt Requested. The foreign sales offices are being notified via e-mail (started on 3/12/10) so that they in turn can notify the foreign consignees of the recall action and report back to Carestream Health. The letter describes the products, problem and action to be taken by the customers. The customers should identify and remove from inventory shelves any product that is listed in the recall, complete and return the attached Product Information Form whether they have affected product or not by fax to Carestream Health Customer Service 1-800-445-9967. Carestream Health will organize the return through designated carriers and will pay for transportation; and supply replacement stock in a timely manner. If you have any questions, concerns, or product technical questions, please call or fax Customer Service or Technical support at 1-800-328-2910.

Device

Device Recall KODAK TMAT L/RA Film
  • 모델명 / 제조번호(시리얼번호)
    Lot 533 012
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and Puerto Rico, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand
  • 제품 설명
    KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 || Intended use: Imaging film
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • 제조사 주소
    Carestream Health, Inc., 150 Verona Street, Rochester NY 14608-1733
  • 제조사 모회사 (2017)
    ONEX Corp
  • Source
    USFDA