Events

HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Health Care Manufacturing 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
    27108
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0729-03
  • 사례 시작날짜
    2003-05-15
  • 사례 출판 날짜
    2003-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-11-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29207
  • 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
    Required labeling (certification and manufacturer's label) was missing from the operator control panels.
  • 조치
    The firm initiated recall with telephone calls approximately 5/15/03 requesting the dealers to provide customer names so they could send corrective labels directly to the users.

Device

HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3...
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 108, 111, 140, 153, 160, 180, 214, 217, 238, 242, 246, 247, 251 thru 254, 256 thru 267, 269 thru 272, 275, 276, 279, 280, 283, 284, 287, 288, 289, 302 thru 318, 321, 322, 323, 330 thru 334, 352, and 1001 thru 1407.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to dealers located nationwide.
  • 제품 설명
    HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
  • Manufacturer
    Health Care Manufacturing Inc

Manufacturer

Health Care Manufacturing Inc
  • 제조사 주소
    Health Care Manufacturing Inc, 2146 East Pythian, Springfield MO 65802
  • Source
    USFDA