Recalls / —

—#97014

Product

PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.

FDA product code

MUJ — System, Planning, Radiation Therapy Treatment

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K022411

Affected lot / code info

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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern

Worldwide distribution: USA and country of: Mexico.

Timeline

Recall initiated

2008-02-05

Posted by FDA

2011-03-04

Terminated

2011-04-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #97014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.