Reported Aug 7, 2019 · Ongoing
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
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 · 13723 Riverport Dr Ste 100 · Maryland Heights, MO · 63043-4819
Is this the product you have?
- Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Lot codes and dates
- all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
- Amount recalled
- 1396 units
Why it was recalled
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
This product could cause temporary or reversible health problems — stop using it.
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