Z-2002-2012Class II

Focal SIM Planning of radiation therapy

Name: Z-2002-2012 Focal SIM Planning of radiation therapy
Creator: Elekta, Inc.
Published: 2012-06-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-06-21 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Focal SIM Planning of radiation therapy on 2012-06-21. FDA classified it as Class II and gives the reason as "Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports". 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-2002-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-21
Posted: 2012-07-12
Terminated: 2014-04-01
Recalling firm: Elekta Limited
Product: Focal SIM Planning of radiation therapy
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Root cause tag: software
FDA root cause: Software design
Action: IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.
Quantity in commerce: 38 units
Distribution: Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
Product codes and lots: Version 4.64.00 - 4.700, inclusive

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2002-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2002-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-12

Product code MUJ

K013112Class IIFocal SimComputerized Medical Systems, Inc. / cleared 2001-12-05

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)