Events

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Burton Medical Products Corp 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
    28229
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0589-04
  • 사례 시작날짜
    2004-02-19
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31412
  • 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
    Device, Medical Examination, Ac Powered - Product Code KZF
  • 원인
    Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
  • 조치
    Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.

Device

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufacture...
  • 모델명 / 제조번호(시리얼번호)
    See Product Description
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.
  • Manufacturer
    Burton Medical Products Corp

Manufacturer

Burton Medical Products Corp
  • 제조사 주소
    Burton Medical Products Corp, 21100 Lassen St, Chatsworth CA 91311-4250
  • Source
    USFDA