Company: Elekta Inc.
Date of Enforcement Report: 9/10/2014
Class lI:
PRODUCT
Focal Sim Product Usage: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be able to perform CT simulations and forward their information to the RTP System for dose calculation.
Recall Number Z-2574-2014
REASON
When DICOM’s 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.
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA on 8/18/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
554 Units
DISTRIBUTION
Nationwide and internationally
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