PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments.
This recall has been terminated (originally issued March 16, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- September 30, 2008
- Posted
- March 16, 2010
- Terminated
- December 28, 2010
- Recall Number
- Z-1109-2010
- Quantity
- 280 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Discontinue use of this method of creating a patient case until FCO 772 00 540 064, (entitled "Update for Patient creation method using DICOM CT with Body Outline"), is received from Elekta to update th
Distribution
United States -- (AL, AK, AZ, AR, CA, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, , NC, OH, OK,OR, PA, SC, TN, TX, VA, WA and WI) & France.
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, 0800690E984E, 08006905C04D, 0800690A02F3, 0800690A47CF, 0800690C1E5A, 0800690EAE97, 08006906D9B0, 08006906D94E, 0800691050D5, 0800690AB49C, 0800690C9357, 0800690AC0A3, 0800690ABEE0, 0800690C1DF2, 0800690C21B1, 0800690ABF4D, 0800690A0FE1, 080069AB4C1, 0800690906AE, 08006907F138, 08006909F10F, 080069090953, 080069EC1DD, 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, 08006907D6B8, 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, 08006907C7A1, 080069076BF4, 0800690C9B17, 0800690C2B4E, 08006905C433, 08006905BE74, 08006905E723, 08006905A225, 0800690883C8, 08006909673B, 0800690C9AA2, 08006907BB7E, 08006907023, 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, 0800690A37AE, 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, 080069A0FE2, 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, 0800690A85FB, 0800690949E1, 080069107CB2, 80069104499, 80069100706, 0800690C1E69, 08006910621E, 0049434409 and 1116245379.
Root Cause
Other
Action Taken
Important Notice A297, "PrecisePLAN release 2.15 with DICOM CT with Body Outline" method of patient creation (dated May 8, 2007) was distributed to all customers. An additional Field Change Order 540 073, dated September 30, 2008 was distributed to customers. Important Notice A316 "Cancellation of Important Notice for PrecisePLAN" was issued. The Important Notice instructed affected users to dispose of Important Notice A297 and replace it with Important Notice A316. If you have any questions regarding the notification, please contact your local Elekta representative directly.