Events

DynaRad Phantom Portable XRay System 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
    36478
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0049-2007
  • 사례 시작날짜
    2006-10-03
  • 사례 출판 날짜
    2006-10-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-01-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48715
  • 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
    Portable X-Ray System - Product Code IZL
  • 원인
    The x-ray tube head assembly of the phantom portable x-ray system may detach from the boom arm assembly. the tube head could fall and contact the patient or operator.
  • 조치
    Del Medical sent Field Correction Recall letters dated 10/3/06 to the direct accounts, informing them of the potential for the shoulder bolt in the yoke assembly to come loose. If the shoulder bolt comes loose, the tube head could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.

Device

DynaRad Phantom Portable XRay System
  • 모델명 / 제조번호(시리얼번호)
    Generator serial numbers: 03460-1003, 03477-1003, 03499-1003, 03550-1003, 03647-1003, 03704-1003, 03734-1003, 03744-1003, 03759-1003, 03765-1003, 03823-1003, 03938-1103, 03941-1103, 03953-1003, 04227-1103, 04282-1203, 04303-1203, 04330-1203, 04477-1203, 04497-1203, 04666-1203, 04704-1203, 00013-0104, 00035-0104, 00107-0104, 00122-0104, 00127-0104, 00188-0104, 00192-0104, 00332-0104, 00336-0104, 00405-0104, 00417-0104, 00430-0104, 00474-0104, 00545-0204, 00555-0204, 00568-0204, 00709-0204, 00719-0204, 00741-0204, 00754-0204, 00776-0204, 00995-0304, 00999-0304, 01101-0304, 01291-0304, 01295-0304, 01369-0304, 01423-0404, 01450-0404, 01468-0404, 01473-0404
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Thailand
  • 제품 설명
    DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)
  • 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