Z-2574-2014Class II

FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of...

Name: Z-2574-2014 FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of...
Creator: Elekta, Inc.
Published: 2014-08-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-08-18 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT... on 2014-08-18. FDA classified it as Class II and gives the reason as "When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan". 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-2574-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-18
Posted: 2014-09-03
Terminated: 2017-08-08
Recalling firm: Elekta Limited
Product: FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
Root cause tag: software
FDA root cause: Software design
Action: Elekta, Inc. issued an Urgent Important Field Safety Notice letter (IFSN 382-01-MON-001) to all affected customers.. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in a patch to Focal 4.80. Development is underway with a release date of September 2014 with confirmation of installation of the patch for the fix no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers (FCO: 382-01-MON-001 VID:2.0). For questions contact your local Elekta office.
Quantity in commerce: 554 units
Distribution: Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech republic, Ecuador, Egypt, Estonia, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Pakistan Portugal, Romania, Russia, Saudi Arabia, Singapore, Solvenia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom
Product codes and lots: Software versions 4.70.00 & 4.80.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2574-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2574-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-03

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)