FOCAL Sim Workstation recall
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT…
Why was FOCAL Sim Workstation 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions 4.70.00 & 4.80.00
- Product
- FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT…
- Recalling firm
- Elekta, Inc.
- Quantity
- 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
- Recall date
- September 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)