Events

Device Recall Leica M822 Surgical Microscope 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Microsystems, 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
    60866
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1042-2012
  • 사례 시작날짜
    2011-12-21
  • 사례 출판 날짜
    2012-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106953
  • 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
    Stimulator, caloric-water - Product Code ETP
  • 원인
    Leica microsystems received complaints stating that the zoom function of the leica m822 surgical microscope locked up during use.
  • 조치
    The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to elizabeth.culotta@leica-microsystems.com. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade. If you have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.

Device

Device Recall Leica M822 Surgical Microscope
  • 모델명 / 제조번호(시리얼번호)
    Article 10448446, serial numbers 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004. The corrected units will have controller software version MDC V3.6 pack G
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.
  • 제품 설명
    Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland || The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • 제조사 주소
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA