Z-1109-2010

PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy...

Name: Z-1109-2010 PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy...
Creator: Elekta, Inc.
Published: 2008-09-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-09-30 / Terminated

FDA source

Elekta, Inc. began a recall of PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments on 2008-09-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1109-2010
Status: Terminated
Initiated: 2008-09-30
Posted: 2010-03-16
Terminated: 2010-12-28
Recalling firm: Elekta Limited
Product: PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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
FDA root cause: Other
Action: 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.
Quantity in commerce: 280 units
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.
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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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)