Z-1476-2011

PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments

Name: Z-1476-2011 PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments
Creator: Elekta, Inc.
Published: 2008-01-28
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-01-28 / Terminated

FDA source

Elekta, Inc. began a recall of PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments on 2008-01-28. The reason FDA records is "PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1476-2011
Status: Terminated
Initiated: 2008-01-28
Posted: 2011-03-02
Terminated: 2011-04-21
Recalling firm: Elekta Limited
Product: PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
FDA root cause: Other
Action: 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. .
Quantity in commerce: 277 units
Distribution: 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,
Product codes and lots: 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

Product code MUJ

K022411Class IIPreciseplan 2.0Precision Therapy Intl., Inc. / cleared 2002-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)