Events

Recall of Device Recall PrecisePLAN Treatment Planning System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1556-2011
  • Event Initiated Date
    2008-02-05
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97014
  • Notes / Alerts
    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.
  • Extra notes in the data
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    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.
  • Action
    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
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and country of: Mexico.
  • Product Description
    PrecisePLAN Treatment Planning System || Intended use: To plan multiple beam radiation therapy treatments.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA