Events

Device Recall Leica Footswitch, Type B 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
    55241
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1632-2010
  • 사례 시작날짜
    2010-03-29
  • 사례 출판 날짜
    2010-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90391
  • 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
    surgical microscope footswitch - Product Code FSO
  • 원인
    The pedals of the footswitch type b stick and the zoom/focus moves to the end position.
  • 조치
    Leica Microsystems sent Medical Device Correction letters dated 3/29/10 to the affected customers via first class mail on the same date, informing them of the potential for injury to the patient's eye if the cross pedal of the footswitch sticks. They were informed that their local Leica Microsystems representative will contact them to arrange for the replacement of the cross pedal. The letters also provided the interim necessary steps required to avoid the risk of patient injury while they are awaiting the cross pedal replacement, i.e. do not use the affected footswitches with a surgical microscope that has a BIOM accessory. The accounts were requested to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. A company contact was provided in the letter for questions.

Device

Device Recall Leica Footswitch, Type B
  • 모델명 / 제조번호(시리얼번호)
    stock number 10445599, serial numbers 90909001 and 301109002;  stock number 10445600, serial numbers 91009001, 81209001, 80909001, 8011001, 71009002, 71009001, 70110002, 61009002, 41209004, 41209002, 291009004, 271009004, 261109001, 250909001, 230909001, 211209005, 211209004, 211009004, 180909002, 180909001, 180110002, 171209002, 161209002, 160909001, 151209001, 140110001, 121009001, 120110002, 120110001, 111209002, 111209001, 110909003, 110909002, 110909001, 11009003, 101209003, 101209002, 101109002 and 100909001; stock number 10448164, serial numbers 80909001, 71209001, 70909002, 31209004, 31209003, 31209002, 31209001, 301009001, 300909001, 291009001, 290909002, 290909001, 240909002, 240909001, 230909001, 180909005, 180909004, 160909002, 100909002 and 100909001;
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia
  • 제품 설명
    Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : || a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; || b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; || c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • 제조사 주소
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA