Events

Device Recall Visum LED Surgical Lights/ Visum Halogen Surgical Lights 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Communications 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
    59866
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0137-2012
  • 사례 시작날짜
    2011-08-23
  • 사례 출판 날짜
    2011-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103892
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • 원인
    Installation records for the switchpoint infinity, booms, lights, and flat panel systems are incomplete or inadequate.
  • 조치
    Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.

Device

Device Recall Visum LED Surgical Lights/ Visum Halogen Surgical Lights
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: 0682001250, 0682001251, 0682000106, and 0682000107. All product distributed and installed between July 2004 and March 2011.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.
  • 제품 설명
    Visum LED Surgical Lights/ Visum Halogen Surgical Lights. || Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 || Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • 제조사 주소
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA