Events

Device Recall Aerial Wheelchair Cushion 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bock,Otto,Orthopedic Ind,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
    67576
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1266-2014
  • 사례 시작날짜
    2014-01-31
  • 사례 출판 날짜
    2014-03-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125745
  • 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
    Cushion, wheelchair - Product Code IMP
  • 원인
    Otto bock is recalling all aerial and aerial active wheelchair cushions from specific material numbers. during internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. the cushions should either be returned to otto bock or destroyed.
  • 조치
    An Urgent Voluntary Device Recall letter was sent to customers beginning 1/31/2014. The letter identified the affected material numbers, described the reason for recall, and asked that product be returned or destroyed. A response Questionnaire was asked to be completed and returned.

Device

Device Recall Aerial Wheelchair Cushion
  • 모델명 / 제조번호(시리얼번호)
    all cushions with the following material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Bosnia and Herzegovina, Brazil, China, Columbia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
  • 제품 설명
    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • 제조사 주소
    Bock,Otto,Orthopedic Ind,Inc, Two Carlson Parkway North, Suite 100, Minneapolis MN 55447
  • Source
    USFDA