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.
Reported: September 10, 2014 Initiated: August 18, 2014 #Z-2574-2014
Product Description
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.
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 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
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Elekta, Inc.. Units affected: 554 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2574-2014.
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