Elekta, Inc.: PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments.

Recall number

Z-1109-2010

Recalling firm

Elekta, Inc.

Product

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

Status

Terminated

Initiated

2008-09-30

Posted

2010-03-16

Terminated

2010-12-28

Reason

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

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

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.

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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