Events

Device Recall AMO WaveScan WaveFront System v3.65 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 VISX INCORPORATED, A SUBSIDIARY OF AMO 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
    47824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1695-2008
  • 사례 시작날짜
    2006-11-17
  • 사례 출판 날짜
    2008-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-06-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70284
  • 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
    Excimer Laser System - Product Code LZS
  • 원인
    Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided lasik treatment at a facility in germany. the probability of a recurrence of this error was determined to be extremely remote. to ensure that this type of incident will not happen again, a software update was developed.
  • 조치
    VISX issued a notification letter on November 27, 2006, to all distributors and direct accounts. The letter informed the recipients that they were performing a field correction in the form of a mandatory upgrade on all VISX WaveScan WaveFront Systems and Offline Programming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Programming Modules using an enclosed CD.

Device

Device Recall AMO WaveScan WaveFront System v3.65
  • 모델명 / 제조번호(시리얼번호)
    All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
  • 제품 설명
    Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
  • Manufacturer
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC

Manufacturer

VISX INCORPORATED, A SUBSIDIARY OF AMO INC
  • 제조사 주소
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC, 3400 Central Expy, Santa Clara CA 95051-0703
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA