Device Recall Rotating IV Pole 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ohmeda Medical 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
    79452
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1181-2018
  • 사례 시작날짜
    2017-12-01
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Stand, infusion - Product Code FOX
  • 원인
    There is the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.
  • 조치
    On December 1, 2017 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers notifying of the recall. The letter requested customers to discontinue use of the affected Rotating IV poles and remove from Service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact you to arrange for the removal & replacement of a new IV pole. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. For further questions, please call (410) 888-5376.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA (nationwide)
  • 제품 설명
    Rotating IV Pole || Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • 제조사 모회사 (2017)
  • Source
    USFDA