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
    57693
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1556-2011
  • 사례 시작날짜
    2008-02-05
  • 사례 출판 날짜
    2011-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97014
  • 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
    When using the 'beam edit" function to modify a bean in an unlocked fraction group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.
  • 조치
    The firm, Elekta, sent an "Important Notice A312" titled "Unintentional Modification of a locked fraction group in PrecisePLAN" dated February 5, 2008 to all affected customers. The notice described the product, problem and action to be taken. The customers were instructed to use care when using the "Make Opposed" function and when changing the Fraction Group of a beam. The customers were also advised to review the final plan and any locked fraction groups to make sure the planned beam arrangement is what was intended. Note: A Field Change Order 540 073 "All PrecisePLAN 2.15 users" was issued on September 30, 2008 to all customers. If you have any questions, call 770-670-2548 or +44(0)1293 654400.

Device

Device Recall PrecisePLAN Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    0800690C208F, 0800690C2228, 0800690C934D, 080069107C11, 08006907BB7F, 08006907B074, 08006907B129, 08006907BB7D, 0800690E964F, 0800690EA07F, 08006909355C, 08006902E7CF, 08006907BEE0, 08006909DA0F, 0800690A4565, 080069100F06, 080069103003, 080069103015, 080069103265, 08006910326F, 08006907B051, 08006910178B, 0800690A9B6B, 0800690A466D, 08006908EFB4, 080069090A10, 0800690977C2, 08006909D8DE, 08006909D8DA, 0800690937B1, 08006908EDF3, 0800690A02F6, 0800690ABEC5, 0800690761D4, 0800690C2229, 0800690AC55A, 0800690A2865, 0800690A25BA, 0800690AB1EE, 080069087078, 0800690883D0, 0800690E9B4E, 08006905C04D, 0800690A02F3, 0800690A47CF, 0800690C1E5A, 0800690EAE97, 08006906D9B0, 08006906D94E, 0800691050D5, 0800690AB49C, 0800690C9357, 080069AC0A3, 0800690ABEE0, 0800690C1DF2, 0800690C21B1, 0800690ABF4D, 0800690A0FE1, 0800690AB4C1, 0800690906AE, 08006907F138, 08006909F10F, 080069090953, 0800690EC1DD, 0800690883CB, 0800690A0FF6, 0800690A0FEF, 0800690C9148, 0800690A8793, 0800690A02F5, 08006902E9E0, 08006902E7D1, 0800690C9B7B, 08006902E7F8, 0800690E8CA9, 08006902EA0A, 0800690E7279, 0800690761D1, 0800690841C6, 08006908ED1C, 080069105594, 0800690C0D48, 0800691064DE, 080069087740, 0800690937BB, 080069090260, 08006907CA1C, 08006905E180, 08006905E6BA, 0800690ED67D, 08009607D4EF, 08006907D6BB, 08006907BB82, 08006910762B, 08006910762A, 08006907BB8E, 08006902E7F0, 080069077BB7, 0800690C54B2, 0800690A73DA, 08006909FA29, 0800690978E3, 08006907CA22, 08006907999A, 0800690CECEA, 0800690CDF04, 0800690909AB, 08006902E925, 08006910001E, 08006910623A, 08006910624F, 080069079BB3, 0800690761CF, 08006907DADE, 0800690E72DF, 08006908A3A8, 0800690A02FD, 08006902EB35, 0800691003D7, 080069107262, 0800690E7F53, 08006909D80B, 08006905E498, 08006905E63C, 0800690A0BA5, 0800690ED72E, 0800690ED90E, 08006905A8E6, 080069086F94, 0800690883CD, 080069088319, 0800690EBC3A, 0800690EBBFF, 0800690EBFCA, 0800690A8830, 0800690A8841, 080069076231, 08006907622F, 0800690C90F4, 08006902E918, 080069107342, 080069088273, 08006909F50B, 0800690977ED, 0800690C7A1, 080069076BF4, 0800690C9B17, 0800690C2B4E, 08006905C433, 08006905BE74, 08006905E723, 08006905A225, 0800690883C8, 08006909673B, 080069C9AA2, 08006907BB7E, 080069087023, 08006908706A, 08006909F1BB, 08006909EFA6, 080069099D13, 0800690A2863, 0800690A0FE4, 08006908847A, 080069088463, 0800690A0FE5, 08006909F507, 0800690CED1C,08006907BEDF, 08006905BA2D, 0800690CE165, 08006905EB6E, 080069087A27, 0800690C6356, 0800690E9F8A, 0800690E9AB7, 0800690E82C4, 0800690E7283, 0800690EADC5, 0800690EACE8, 0800690EA40C, 0800690EA365, 080069099D0A, 080069086F92, 0800691077E0, 0800690C2168, 080069090841, 08006908F51D, 080069086630, 0800690907F5, 0800690907CD, 080069104115, 0800690A854C, 0800690A4677, 080069037AE, 080069106B53, 08006910816B, 0800690EAFCF, 0800690CDDA2, 0800690E72F7, 08006909FD0C, 08006909FD1B, 0800690A4670, 08006907BB89, 0800690A9DOE, 0800690A87F2, 08006907BB55, 0800690840A8, 080069087720, 080069076227, 08006908EC10, 0800690937B9, 0800690BD8A4, 080069132DDF, 080069134331, 0800691048A5, 0800690A2507, 0800690E9A67, 0800690A85E1, 0800690A8F4C, 0800690A1438, 0800690A13FB, 0800690A90FD, 0800690E6CF9, 080069102A57, 0800690EC864, 0800690909B4, 0800690A0FE2, 0800690A8E1F, 080069100F95, 080069098EF6, 0800690C1745, 08006909D95A, 0800690A740E, 0800690A7410, 0800690AC55B, 0800690ACA88, 08006909D93B, 080069097A4D, 080069097A4E, 0800690A02FC, 0800690A47CE, 0800690A47E5, 0800690A47AE, 0800691050AF, 0800690A97D1, 0800690A1DC6, 08006907BEB2, 0800690A8F6D, 0800690A8F4F, 0800690EAF6D, 0800690EB40C, 08006907BB6D, 0800690CF7A2, 0800691003C3, 080069100455, 0800690ED7DF, 0800690CE157, 0800690EB787, 0800690ED7CO, 08006910560F, 08006910561E, 080069105607, 0800690ED967, 080069106136, 0800691075FB, 080069107C1F, 080069108174, 08006910762C, 0800690F6E74, 08006902E8DB, 080069106B59, 0800690A85FB, 0800690949E1, 00869107CB2, 0086910662E, 080069107623, 080069107C12, 080069106DB4, 80069104499, 80069100706, 0800690C1E69
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and country of: Mexico.
  • 제품 설명
    PrecisePLAN Treatment Planning System || Intended use: 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