Device Recall STRYKER NAVIGATION SYSTEM OrthoMap 3D Sales Demo SOFTWARE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Division of Stryker Corporation 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
    57487
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1417-2011
  • 사례 시작날짜
    2010-11-10
  • 사례 출판 날짜
    2011-02-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • 원인
    When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. this may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.
  • 조치
    Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification. 2) Distribute this notification to all departments affected. 3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all applications will be available by the end of the year. The upgrades will be scheduled as we receive your business reply form. Note: If you currently have a Time License or Pay Per Use card, a new one will be issued to you at the time of the update. 5) If you have loaned or sold any of the units listed in this notification, please, forward a copy of this notice to the new users and advise Stryker of the new users name and their new location. 6) If you have disposed of any of the affected units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. Questions regarding this recall should be directed to Stryker Field Action Team at 800-800-4236, ext 3808, 3584, or 4354 between the hours of 8 a.m. - 5 p.m. Monday - Friday.

Device

  • 모델명 / 제조번호(시리얼번호)
    All batches: K3X00F3016; K4700F3016; K5500F3016; K7X00F3016; K8S00F3016; K9100F3016; KBC00F3016; and L1V00F3016.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • 제품 설명
    Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
  • Source
    USFDA