Events

Device Recall PrecisePLAN Treatment Planning System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Elekta, 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
    57692
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1476-2011
  • 사례 시작날짜
    2008-01-28
  • 사례 출판 날짜
    2011-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97012
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • 원인
    Preciseplan generates digitally reconstructed radiographs (drr;s) with a shift in the superior direction.
  • 조치
    Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. .

Device

Device Recall PrecisePLAN Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    0800690937B9, 080069079BB3, 0800690CED1C, 080069104499, 0800690E7F53, 0800690C1E5A, 0800690EAE97, 08006902EA0A, 08006902E9E0, 080069107C1F, 08006907BB8E, 08006907BB55, 08006902E7D1, 0800690C934D, 080069104115, 08006909FA29, 0800690978E3, 080069086F92, 0800690A02F6, 080069107C11, 0800690A8F4C, 0800690A90FD, 0800690E6CF9, 0800690CF7A2, 0800691003C3, 080069100455, 0800690ED7C0, 0800690ED7DF, 0800690EB787, 08006910762C, 080069098EF6, 0800690C1745, 0800690CE157, 080069108174, 0800690909B4, 0800690761D1, 08006909F50B, 0800690977ED, 08006909355C, 080069132DDF, 080069100706, 080069107262, 08006909D95A, 08006907CA22, 08006907999A, 0800691064DE, 0800690ED967, 0800691075FB, 0800690ABEC5, 0800690840A8, 080069087720, 080069076227, 08006908EC10, 08006902EB35, 08691003D7, 0800690A13FB, 0800690C208F, 0800690C228, 0800690E9B4E, 080069087740, 08006907CA1C, 08006905E180, 08006905E6BA, 0800690E8CA9, 080069E9AB7, 08006905C433, 08006907BEDF, 08006905BA2D, 0800690A8793, 0800690A02F5, 080069090841, 08006908F51D, 080069086630, 0800690907F5, 0800690907CD, 0800690A740E, 0800690A7410, 0800690AC55B, 0800690ACA88, 08009607D4EF, 08006907D6B8, 08006907BB82, 0800690A0FE2, 0800690A8E1F, 080069100F95, 0800690937B1, 08006908EDF3, 080069107CB2, 0800690E964F, 0800690EA07F, 0800690883CB, 0800691077E0, 08006910561E, 0800690EC1DD, 0800690E72DF, 08006907C7A1, 080069076BF4, 0800690C9B17, 0800690A0FF6, 0800690A0FEF, 0800690C9148, 0800690A2863, 0800690906AE, 08006907F138, 08006905E498, 0800690ED72E, 0800690ED90E, 0800690C90F4, 08006902E918, 0800690E9F8A, 08006905E723, 08006908ED1C, 080069105594, 0800690C0D48, 0800690AB49C, 0800690C9357, 0800690A02F3, 0800690A47CF. 0800690C54B2, 08006909F10F, 08006907BB89, 08006907BB7F, 08006907B074, 08006907B129, 08006907BB7D, 08006902E7CF, 0800690C1DF2, 0800690C9B7B, 08006905E63C, 0800690A0BA5, 08006909D93B, 080069097A4D, 080069097A4E, 0800690C9AA2, 0800690AC0A3, 0800690ABEE0, 080069086F94, 0800690883CD, 080069088319, 0800690A8830, 0800690A8841, 080069090953, 0800690761D4, 0800690C229, 08006907BEE0, 080069076231, 08006907622F, 080069107342, 08006909D80B, 080069099D0A, 0800690ED67D, 08006910560F, 080069105607, 080069106136, 080069088273, 080069A14138, 08006907BEB2, 0800690A8F6D, 0800690A8F4F, 0800690EAF6D, 0800690EB40C, 08006907BB6D, 0800690C1E69, 08006905A8E6, 08006905A225, 08006908A3A8, 0800690A02FD, 0800690A854C, 0800690A4677, 0800690A37AE, 08006905C04D, 08006909FD0C, 08006909FD1B, 0800690A4670, 08006906D9B0, 08006906D94E, 080069087078, 0800690883D0, 0800690977C2, 08006909D8DE, 08006909D8DA, 08006908706A, 08006909F1BB, 0800690A9B6B, 0800690A466D, 08006909DA0F, 0800690A4565, 080069100F06, 080069103003, 08869103015, 080069103265, 08006910326F, 08006902E7F8, 0800690E7279, 08006902E7F0, 0800690A0FE4, 08006909F507, 0800690EA365, 0800690C6356, 08006907BB7E, 0800690EA40C, 080069085E1, 080069102A57, 0800690EC864, 080069.0EAFCF, 08006910001E, 08006910623A, 08006910624F, 08006907B051, 08006910178B, 0800690EBC3A, 0800690EBBFF, 0800690EBFCA, 0800690A2507, 0800690E9A67, 0800690909AB, 08006902E925, 0800691050AF, 0800690ABF4D, 0800690A0FE1, 0800690AB4C1, 0800690AC55A, 0800690A2865, 0800690A25BA, 0800690AB1EE, 0800690C2168, 0800690A85FB, 0800690949E1, 080069106B53, 08006910816B, 0800690A73DA, 08006908EFB4, 080069090A10, 0800690C2B4E, 0800690883C8, 08006909673B, 0800690A0FE5, 08006905BE74, 080069087023, 0800690E82C4, 080069088463, 08006909EFA6, 080069099D13, 0800690EACE8, 08006908847A, 0800690EADC5, 0800691050D5, 0800690A97D1, 088690A1DC6, 0800690BD8A4, 080069134331, 0800691048A5, 0800690F6E74, 0800690841C6, 08800690C21B1, 0800690A9D0E, 0800690A87F2, 0800690CECEA, 0800690CDF04, 08700690761CF, 08006907DADE, 0800690CDDA2, 0800690E72F7, 0800690A02FC, 0800690A47CE, 0800690A47E5, 0800690A47AE, 08006902E8DB, 08006910762B, 08006910762A, 0800690CE165, 080069077BB7, 08006905EB6E, 080069087A27, 0800690E7283, 0800690937BB, 080069090260, 08006910621E
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak Republic, Australia, China, Hong Kong, and Japan,
  • 제품 설명
    PrecisePLAN Treatment Planning System || To plan multiple beam radiation therapy treatments.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • 제조사 주소
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA