Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FOCAL Sim Workstation Recalled by Elekta, Inc. Due to When DICOM is exporting an arc plan (VMAT,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elekta, Inc. directly.
Affected Products
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.
Quantity: 554 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Elekta, Inc.
Elekta, Inc. has 100 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report