Recalls / —

—#129201

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.

FDA product code

MUJ — System, Planning, Radiation Therapy Treatment

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013112

Affected lot / code info

Software versions 4.70.00 & 4.80.00

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

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

Timeline

Recall initiated

2014-08-18

Posted by FDA

2014-09-03

Terminated

2017-08-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #129201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.