Events

Karl Storz Photodynamic Diagnosis (PDD) DLight C System, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Karl Storz Endoscopy America 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
    60555
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1216-2013
  • 사례 시작날짜
    2012-08-16
  • 사례 출판 날짜
    2013-05-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117240
  • 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 source system, diagnostic endoscopic - Product Code OAY
  • 원인
    The recall was initiated because karl storz has confirmed that the photodynamic diagnosis (pdd) d-light c system instruction manuals have important safety-related changes.
  • 조치
    A Safety Alert letter, dated 8/16/12, was sent to all their customers to inform them that there is a labeling error in which important safety-related changes were made to the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System instruction manuals. The correct Ethylene Oxide (EtO) Sterilization set point for Relative Humidity should read, =70% RH. The correction applies to the PDD Camera Head instruction manual, PDD Rigid Telescopes instruction manual, and Tricam SL II instruction manual, the three component manuals indicated for use within the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System. The letter instructed the customers to place each of the three enclosed stickers, in the appropriate instruction manual. Customers are instructed to cover the erroneous information with the provided stickers as indicated. Customers with any questions regarding the proper use of the device, are instructed to contact Karl Storz's Technical Support Department at 800-421-0837, Ext. 5350, during office hours; or Ext. 7222, 24 hours/7 days a week for emergencies.

Device

Karl Storz Photodynamic Diagnosis (PDD) DLight C System,
  • 모델명 / 제조번호(시리얼번호)
    The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System.   Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and  TX2035.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
  • 제품 설명
    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, || Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. || Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • 제조사 주소
    Karl Storz Endoscopy America Inc, 2151 East Grand Avenue, El Segundo CA 90245
  • 제조사 모회사 (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA