Device Recall Ossur Lil Angel Vest 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ossur H / F 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
    73382
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1514-2016
  • 사례 시작날짜
    2016-03-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-16
  • 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
    Component, traction, non-invasive - Product Code KQZ
  • 원인
    There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
  • 조치
    Customer notification letter were sent on 03/14/16 via traceable method. The notification asked customers to examine their inventory, quarantine product subject to the recall and contact customer service for a return authorization to return the product to Ossur. Customers were asked to take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the potentially affected devices have been transferred. 2. Maintain awareness on the notice for an appropriate period. 3. If have further distributed this product identify the customers and notify them at once of this product alert. It is recommended that a copy of the notice is included. 4. If any customers are currently wearing a product it is recommended a detailed inspection of the product vest structurebe conducted to ensure there is no visible cracks on the vest.

Device

  • 모델명 / 제조번호(시리얼번호)
    P/N: 545150L units from 2008 to current
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution US Nationwide and Hong Kong
  • 제품 설명
    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • 제조사 모회사 (2017)
  • Source
    USFDA