Events

Tango Reflex 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Laserex Systems 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
    77170
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2172-2017
  • 사례 시작날짜
    2017-04-04
  • 사례 출판 날짜
    2017-06-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155147
  • 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
    It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.
  • 조치
    Ellex Medical shall, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard. 1. Installation of a spacer/collar to prevent the slit lamp from being lowered to the point where the cable can be crushed, 2. Improvement of cable management, 3. The corrections will be conducted at no cost to the purchaser, and 4. The corrective action will be completed by June 30, 2017. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (800) 824-7444.

Device

Tango Reflex
  • 모델명 / 제조번호(시리얼번호)
    Serial No: TR 0010, TR 0095
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    Ellex Tango Reflex with slit lamp Laser Ophthalmic || In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
  • Manufacturer
    Laserex Systems Inc.

Manufacturer

Laserex Systems Inc.
  • 제조사 주소
    Laserex Systems Inc., 7138 SHADY OAK RD, EDEN PRAIRIE MN 55344-3517
  • Source
    USFDA