Z-1406-2010

PrecisePLAN 2.10 Treatment Planning System

Name: Z-1406-2010 PrecisePLAN 2.10 Treatment Planning System
Creator: Elekta, Inc.
Published: 2006-03-15
License: https://open.fda.gov/license/

Elekta Limited / initiated 2006-03-15 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of PrecisePLAN 2.10 Treatment Planning System on 2006-03-15. The reason FDA records is "Error in dose rates which were calculated at exactly twice the expected values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1406-2010
Status: Terminated
Initiated: 2006-03-15
Posted: 2010-04-16
Terminated: 2010-12-30
Recalling firm: Elekta Limited
Product: PrecisePLAN 2.10 Treatment Planning System
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Error in dose rates which were calculated at exactly twice the expected values.
Root cause tag: software
FDA root cause: Software design
Action: As described in a prior related submission, Phase I - "Important Notice A285, Scrolling Selected Frame Dose Calculator Error" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken. Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200.
Quantity in commerce: 40 units
Distribution: Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland
Product codes and lots: 1762685762, 1762688017, 1762688506, 1726288507, 1762676911, 1762688175, 1762689384, 1762688019, 1762688022, 1762688876, 1762689442, 1762688177, 1762690813, 1762686657, 1762689588, 1762689386, 1762684357, 1762686833, 1762684370, 1762678238, 1762689519, 1762684359, 1762690814, 1762688514, 1762578223, 1762678239, 1762684360, 1762684361, 1762684362, 1762684367, 1762683737, 1762682414, 1762688081, 1762686584, 1762686843, 1762686832, 1762688024, 1762688080, 1762686836, 1762684358

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)