Reported Oct 14, 2015 · Terminated
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external…
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?
- Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Lot codes and dates
- Software Version 5.10.00
- Amount recalled
- 154 units
Where it was sold
Why it was recalled
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
This product could cause temporary or reversible health problems — stop using it.
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