FDA Medical Device Recalls (openFDA)
Elekta, Inc.: PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
- Recall number
- Z-1476-2011
- Recalling firm
- Elekta, Inc.
- Product
- PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
- Status
- Terminated
- Initiated
- 2008-01-28
- Posted
- 2011-03-02
- Terminated
- 2011-04-21
- Reason
- PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
- 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
- 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,
- Lot, serial or model codes
- 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
- 510(k) numbers
- K022411
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1037831
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28