Events

Device Recall Rapid Response HUT Table 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Positioning 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
    58035
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1975-2011
  • 사례 시작날짜
    2010-02-01
  • 사례 출판 날짜
    2011-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98168
  • 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
    Tilting Radiologic Table - Product Code IXR
  • 원인
    The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
  • 조치
    An undated Urgent - Voluntary Medical Device Product Correction letter was issued on 2/1/2010 by certified mail with return receipt requested. The letter identified the model and serial numbers of the affected product. The consignees were advised to stop using the table immediately and remove it from service until further notice. Customers were to contact Mr. Joe Hurtig at 1-800-593-3246 or jhurtig@medicalpositioning.com to confirm receipt of the notice and to provide the firm with the correct contact information. Individualized correction packages including replacement parts and instructions were sent to each consignee. The instructions consisted of (1) Rapid Response HUT Motor Replacement Instructions; (2) Control Box Replacement Instructions; and (3) ILD External Power Supply Removal Instructions.

Device

Device Recall Rapid Response HUT Table
  • 모델명 / 제조번호(시리얼번호)
    598972, 599406, 599650, 599707, 599710, 599721, 599771, 599870, 599871, 599964, 600024, 600115, 600333, 600550, 600551, 600655, and 600790 located on the side of the table
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including Puerto Rico, and Canada.
  • 제품 설명
    Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Medical Positioning Incorporated. 800-593-3246. || Used in clinical and hospital settings by trained radiologists.
  • Manufacturer
    Medical Positioning Inc

Manufacturer

Medical Positioning Inc
  • 제조사 주소
    Medical Positioning Inc, 1717 Washington St, Kansas City MO 64108-1121
  • 제조사 모회사 (2017)
    Medical Positioning Inc.
  • Source
    USFDA