Events

Schaerer 7300 surgical table 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Schaerer Medical USA 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
    75288
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0372-2017
  • 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=149954
  • 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
    Table, surgical with orthopedic accessories, manual - Product Code JEB
  • 원인
    The floor locking cylinders are contained in the base of the schaerer 7300 model surgical tables. the cylinders were manufactured with the incorrect "o" ring which may cause the cylinder to leak.
  • 조치
    Schaerer Medical sent a Field action letters dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is required to complete and return a response form with the number of affected tables and cylinders. All affected cylinders will be replaced in the field and returned to the manufacturer. For questions Quality Assurance at 513-272 -9116.

Device

Schaerer 7300 surgical table
  • 모델명 / 제조번호(시리얼번호)
    Lot code of the replacement cylinders, 2016-02-01
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
  • 제품 설명
    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. || Product Usage: || The cylinders are used to lock the surgical table in place.
  • Manufacturer
    Schaerer Medical USA Inc

Manufacturer

Schaerer Medical USA Inc
  • 제조사 주소
    Schaerer Medical USA Inc, 675 Wilmer Ave, Cincinnati OH 45226-1802
  • 제조사 모회사 (2017)
    Schaerer Medical Usa Inc.
  • Source
    USFDA