Elekta, Inc.: PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.

Recall number

Z-1556-2011

Recalling firm

Elekta, Inc.

Product

PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.

Status

Terminated

Initiated

2008-02-05

Posted

2011-03-04

Terminated

2011-04-07

Reason

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.

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

282 units

Distribution

Worldwide distribution: USA and country of: Mexico.

Lot, serial or model codes

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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

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

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