Z-1556-2011

PrecisePLAN Treatment Planning System

Name: Z-1556-2011 PrecisePLAN Treatment Planning System
Creator: Elekta, Inc.
Published: 2008-02-05
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-02-05 / Terminated

FDA source

Elekta, Inc. began a recall of PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments on 2008-02-05. The reason FDA records is "When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1556-2011
Status: Terminated
Initiated: 2008-02-05
Posted: 2011-03-04
Terminated: 2011-04-07
Recalling firm: Elekta Limited
Product: PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.
FDA root cause: Other
Action: The firm, Elekta, sent an "Important Notice A312" titled "Unintentional Modification of a locked fraction group in PrecisePLAN" dated February 5, 2008 to all affected customers. The notice described the product, problem and action to be taken. The customers were instructed to use care when using the "Make Opposed" function and when changing the Fraction Group of a beam. The customers were also advised to review the final plan and any locked fraction groups to make sure the planned beam arrangement is what was intended. Note: A Field Change Order 540 073 "All PrecisePLAN 2.15 users" was issued on September 30, 2008 to all customers. If you have any questions, call 770-670-2548 or +44(0)1293 654400.
Quantity in commerce: 282 units
Distribution: Worldwide distribution: USA and country of: Mexico.
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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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)