Events

Device Recall 2 over 2 elevating monitor suspension system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Omega Medical Imaging, 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
    77458
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2621-2017
  • 사례 시작날짜
    2017-03-23
  • 사례 출판 날짜
    2017-06-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156081
  • 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
    Monitor, patient position, light-beam - Product Code IWE
  • 원인
    Elevating monitor suspension column dropping and will not rise back up.
  • 조치
    The firm, OMEGA MEDICAL IMAGING, sent a "Field Safety Advisory Notice" dated 3/23/2017 to consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to immediately examine the product and confirm correct product information; immediately discontinue use; move monitor suspension away from staff personnel and patients; and advising consignees to take photos of affected product and the P/N label. Photos of product labels are to be sent to jnewman@omegamedicalimaging.com at Omega. Product is to be corrected. If there are any questions or concerns, please feel free to contact us at 407-323-9400 Ext 203 or email: omegamedicalimaging.com or jnewman@omegamedicalimaging.com.

Device

Device Recall 2 over 2 elevating monitor suspension system
  • 모델명 / 제조번호(시리얼번호)
    SKF Telescopic Pillar P/N ending in -003
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
  • 제품 설명
    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory || Device accessory that elevates monitor for healthcare professionals.
  • Manufacturer
    Omega Medical Imaging, Inc.

Manufacturer

Omega Medical Imaging, Inc.
  • 제조사 주소
    Omega Medical Imaging, Inc., 675 Hickman Cir, Sanford FL 32771-6931
  • Source
    USFDA