Z-1244-2015Class II

Focal Sim radiation therapy treatment planning system

Name: Z-1244-2015 Focal Sim radiation therapy treatment planning system
Creator: Elekta, Inc.
Published: 2014-12-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-12-19 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Focal Sim radiation therapy treatment planning system on 2014-12-19. FDA classified it as Class II and gives the reason as "Incorrect CT to ED when using the Monaco Image Statistics Tool". 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-1244-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-03-04
Terminated: 2017-08-07
Recalling firm: Elekta Limited
Product: Focal Sim radiation therapy treatment planning system
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect CT to ED when using the Monaco Image Statistics Tool.
Root cause tag: software
FDA root cause: Software design
Action: An Important User Notice (IUN 382-03-FCL-001) was issued to customers on 12/19/2014. The notice included a workaround to be used until a new software release. The notice also included an acknowledgement form to be returned.
Quantity in commerce: 907
Distribution: Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.
Product codes and lots: Focal Release 4.80

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1244-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1244-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)