Events

Device Recall WaveScan WaveFront System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Visx 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
    39353
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0365-2008
  • 사례 시작날짜
    2007-05-30
  • 사례 출판 날짜
    2008-01-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55273
  • 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
    Erroneous treatment calculations - two software caused errors; in combination, in the wavescan system software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) installation of software for a certain brand of computer (dedicated computing llc) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the "off.
  • 조치
    AMO sent an Action Required notification on May 30, 2007, to AMO Certified Physicians. The letter included a CD software update (0070-1721) to be installed by users that provided correct registry parameter settings. Upon completion of installation, a confirmation form will print out. Customers are requested to fax back confirmation to AMO (408-773-7055).

Device

Device Recall WaveScan WaveFront System
  • 모델명 / 제조번호(시리얼번호)
    System Serial Numbers affected include: 75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391, 75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091, 76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111, 76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123, 76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033, 76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146, 76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032, 76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431, 75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126, 76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021, 76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163, 70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890, 75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037, 76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150, 76151, 76153, 76155, 76156, 76157, 76159, 76160,76162, 70272, 70280, 70297, 70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397, 75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439, 76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734, 76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864, 75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406, 75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005, 75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178, 76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060, 70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107, 70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440, 76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580, 70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072, 76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241, 70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and 76041
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.
  • 제품 설명
    Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
  • Manufacturer
    Visx Inc

Manufacturer

Visx Inc
  • 제조사 주소
    Visx Inc, 3400 Central Expressway, Santa Clara CA 95051
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA