MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Hazard
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
What You Should Do
Elekta notified customers on about 12/04/2018 via letter titled, "Urgent Important Field Safety Notification." The letter contains recommended user action and that appropriate personnel working with the device should be advised on the content of the letter and the letter should be placed in an area accessible to all users. The letter stated that the issue will be resolved in Service Packs to MOSAIQ Releases 2.64, 2.65 and 2.70. Customers will be informed when the fix is available through a Product Bulletin. An acknowledgement Form was sent as part of the letter to be completed and returned no later than 30 days. The firm can be contacted at 408-830-8000 or 855-693-5358.
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Products
- Brand
- Elekta, Inc.
- UPC
- Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235
Units Affected
551 units