Events

SideFire Directional Laser Probe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Monteris Medical 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
    69514
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0227-2015
  • 사례 시작날짜
    2014-10-03
  • 사례 출판 날짜
    2014-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130786
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    Monteris medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
  • 조치
    Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by user: Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment. Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.

Device

SideFire Directional Laser Probe
  • 모델명 / 제조번호(시리얼번호)
    serial numbers: 20368-1-C1112-01, 20368-1-C1112-02, 20368-1-C1112-03, 20368-1-C1112-04, 20368-1-C1112-05, 20368-1-C1112-06, 20368-1-C1112-07, 20368-1-C1112-08, 20368-1-C1112-09, 20368-1-C3173-02, 20368-1-C3173-03, 20368-1-C3173-04, 20368-1-C3173-05, 20368-1-C3173-06, 20368-1-C3173-07, 20368-1-C3173-08, 20368-1-C3173-09, 20368-1-C3173-10, 20368-1-C3173-11, 20368-1-C3173-12, 20368-1-C3173-13, 20368-1-C3173-14, 20368-1-C3173-15, 20368-1-C3173-16, 20368-1-C3173-17, 20368-1-C3173-18, 20368-1-C3173-19, 20368-1-C3173-20, 20368-1-C3258-01, 20368-1-C3258-02, 20368-1-C3258-04, 20368-1-C3258-05, 20368-1-C3258-06, 20368-1-C3258-07, 20368-1-C3258-12, 20368-1-C3258-13, 20368-1-C3258-14, 20368-1-C3462-01, 20368-1-C3462-02, 20368-1-C3462-03, 20368-1-C3462-04, 20368-1-C3462-05, 20368-1-C3462-06, 20368-1-C3462-07, 20368-1-C3462-08, 20368-1-C3462-09, 20368-1-C3462-10, 20368-1-C3462-11, 20368-1-C3462-12, 20368-1-C3462-13, 20368-1-C3462-14, 20368-1-C3462-16, 20368-1-C3462-17, 20368-1-C3462-18, 20368-1-C3462-19, 20368-1-C3462-22, 20368-1-C3462-24, 20368-1-C3462-25, 20368-1-C3756-01, 20368-1-C3756-02, 20368-1-C3756-04, 20368-1-C3756-05, 20368-1-C3756-06, 20368-1-C3756-07, 20368-1-C3756-08, 20368-1-C3756-11, 20368-1-C3756-12, 20368-2-C1276-02, 20368-2-C1276-04, 20368-2-C1276-05, 20368-2-C1276-06, 20368-2-C1276-07, 20368-2-C1276-08, 20368-2-C1276-09, 20368-2-C1276-11, 20368-2-C1276-12, 20368-2-C1276-13, 20368-2-C1276-14, 20368-2-C1276-15, 20368-2-C1276-16, 20368-2-C1276-17, 20368-2-C1276-18, 20368-2-C1276-19, 20368-2-C1276-20, 20368-2-C1276-21, 20368-2-C1276-22, 20368-2-C3287-01, 20368-2-C3287-02, 20368-2-C3287-03, 20368-2-C3287-04, 20368-2-C3287-05, 20368-2-C3287-06, 20368-2-C3287-07, 20368-2-C3287-08, 20368-2-C3287-09, 20368-2-C3287-10, 20368-2-C3287-11, 20368-2-C3287-12, 20368-2-C3287-13, 20368-2-C3287-14, 20368-2-C3287-15, 20368-2-C3287-16, 20368-2-C3287-17, 20368-2-C3287-19, 20368-2-C3287-20, 20368-2-C3287-21, 20368-2-C3287-22, 20368-2-C3472-01, 20368-2-C3472-02, 20368-2-C3472-03, 20368-2-C3472-04, 20368-2-C3472-05, 20368-2-C3472-06, 20368-2-C3472-07, 20368-2-C3472-08, 20368-2-C3472-09, 20368-2-C3472-10, 20368-2-C3472-11, 20368-3-C1115-01, 20368-3-C1115-02, 20368-3-C1115-03, 20368-3-C1115-04, 20368-3-C1115-05, 20368-3-C1115-06, 20368-3-C1115-07, 20368-3-C1115-08, 20368-3-C1115-09, 20368-3-C1115-10, 20368-3-C1116-01, 20368-3-C1116-02, 20368-3-C1116-04, 20368-3-C1116-05, 20368-3-C1116-06, 20368-3-C3293-01, 20368-3-C3293-02, 20368-3-C3293-03, 20368-3-C3293-04, 20368-3-C3293-05, 20368-3-C3293-07, 20368-3-C3293-10, 20368-3-C3293-11, 20368-3-C3293-13, 20368-3-C3293-14, 20368-3-C3293-15, 20368-3-C3293-16, 20368-3-C3293-17, 20368-3-C3293-19, 20368-3-C3293-20, 20368-3-C3293-21, 20368-3-C3293-23, 20368-3-C3452-04, 20368-3-C3452-06, 20368-3-C3452-07, 20368-3-C3452-09, 20368-3-C3452-10, 20368-3-C3452-11, 20368-3-C3452-13, 20368-3-C3452-14, 20368-3-C3452-15, 20368-3-C3452-17, 20368-3-C3452-18, 20368-3-C3452-20, 20368-3-C3452-21, 20368-3-C3452-22, 20368-3-C3452-24, 20368-3-C3452-25, 20368-3-C3512-01, 20368-3-C3512-02, 20368-3-C3512-03, 20368-3-C3512-04, 20368-3-C3512-05, 20368-3-C3512-06, 20368-3-C3512-08, 20368-4-C1117-01, 20368-4-C1117-02, 20368-4-C1117-03, 20368-4-C1117-05, 20368-4-C1117-06, 20368-4-C1117-08, 20368-4-C1117-09, 20368-4-C1117-10, 20368-4-C3166-01, 20368-4-C3166-02, 20368-4-C3166-03, 20368-4-C3166-04, 20368-4-C3166-05, 20368-4-C3166-06, 20368-4-C3166-07, 20368-4-C3166-08, 20368-4-C3166-09, 20368-4-C3166-10, 20368-4-C3166-12, 20368-4-C3166-13, 20368-4-C3166-14, 20368-4-C3166-15, 20368-4-C3166-16, 20368-4-C3166-17, 20368-4-C3166-18, 20368-4-C3166-19, 20368-4-C3166-20, 20368-4-C3264-01, 20368-4-C3264-02, 20368-4-C3264-03, 20368-4-C3264-04, 20368-4-C3264-06, 20368-4-C3264-08, 20368-4-C3264-09, 20368-4-C3264-10, 20368-4-C3264-12, 20368-4-C3264-14, 20368-4-C3264-15, 20368-4-C3264-16, 20368-4-C3264-17, 20368-4-C3264-18, 20368-4-C3264-19, 20368-4-C3264-21, 20368-4-C3264-22, 20368-4-C3264-24, 20368-4-C3264-25, 20368-5-C1118-03, 20368-5-C1118-04, 20368-5-C1118-05, 20368-5-C3298-03, 20368-5-C3298-04, 20368-5-C3298-05, 20368-5-C3298-06, 20368-5-C3298-07, 20368-5-C3298-08, 20368-5-C3298-09, 20368-5-C3298-10, 20368-5-C3798-01, 20368-5-C3798-02, 20368-5-C3798-21, 20368-5-C3798-22.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
  • 제품 설명
    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
  • Manufacturer
    Monteris Medical Corp

Manufacturer

Monteris Medical Corp
  • 제조사 주소
    Monteris Medical Corp, 16305 36th Ave N Suite 200, Plymouth MN 55446-2884
  • 제조사 모회사 (2017)
    Monteris Medical Corp
  • Source
    USFDA