Events

Device Recall Del Medical DCTM Ceiling Tube Mount 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Del Medical Systems Group 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
    28372
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0712-04
  • 사례 시작날짜
    2004-02-13
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-09-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31680
  • 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
    Tube Mount, X-Ray, Diagnostic - Product Code IYB
  • 원인
    There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the digital ceiling mounted tube support system for overhead x-ray units.
  • 조치
    Del Medical sent a Field Correction Recall letter dated 2/13/04 to all dealers/assemblers receiving DCTM''s during the affected time frame, alerting them to potential defective worm gear. The accounts were asked to locate the systems listed in the attachment to the letter, and alert the end users to take the units out of service until they can be inspected. Follow-up letters were sent via registerd mail on 2/19/04, reiterating the 2/13/04 letter and providing the accounts with instructions for inspection of the balancers. If the worm gear fails the test, the dealers were instructed to contact Del Medical for replacement of the balancer and assure that the unit is not placed back in service until the balancer has been replaced.

Device

Device Recall Del Medical DCTM Ceiling Tube Mount
  • 모델명 / 제조번호(시리얼번호)
    Model DCTM, serial numbers 00182-0303, 00337-0303, 00901-0503, 00948-0503, 02082-0703, 02083-0703, 02152-0703, 02153-0703, 02187-0703, 02188-0703, 02289-0703, 02460-0803, 02492-0803, 02493-0803, 02581-0803, 02730-0803, 02805-0803, 02809-0903, 02810-0903, 02811-0903, 02812-0903, 02866-0903, 02918-0903, 02989-0903, 02990-0903, 02991-0903, 03147-0903, 03148-0903, 03149-0903, 03457-1003, 03458-1003, 03544-1003, 03545-1003, 03624-1003, 03625-1003, 03756-1003, 03757-1003, 03888-1103, 03956-1103, 04085-1103, 04122-1103, 04154-1103, 04236-1103, 04248-1103, 04264-1103, 04371-1203, 04433-1203, 04439-1203, 04480-1203, 04529-1203, 04572-1203, 04634-1203, 04659-1203, 04709-1203, 00032-0104, 00085-0104, WG0031-0102-R
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nevada, Ohio, Tennessee, Nebraska, Arizona, Maryland, Wisconsin, Florida, Texas, Kansas, Oklahoma, Illinois, Colorado, California, Minnesota, Michigan, Alabama, Rhode Island and internationally to Canada, Panama and Pakistan
  • 제품 설명
    DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A.
  • Manufacturer
    Del Medical Systems Group

Manufacturer

Del Medical Systems Group
  • 제조사 주소
    Del Medical Systems Group, 11550 West King Street, Franklin Park IL 60131-1330
  • Source
    USFDA