Reported Jan 2, 2019 · Terminated
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
- Lot codes and dates
- Software Build(s)
2.64 SP9 and higherUDI (01)00858164002091(10)2.64.235
- Software Build(s)
- Amount recalled
- 551 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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