Recalls / —

—#97012

Product

PrecisePLAN Treatment Planning System 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

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

Why it was recalled

PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.

Root cause (FDA determination)

Other

Action the firm took

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. .

Recalling firm

Firm

Elekta, Inc.

Address

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

Distribution

Distribution pattern

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,

Timeline

Recall initiated

2008-01-28

Posted by FDA

2011-03-02

Terminated

2011-04-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #97012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.