Reported Jun 8, 2016 · Terminated
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions 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?
- Monaco RTP System Product UsageThe Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy
- Lot codes and dates
- Monaco versions 5.10.00 and higher
- Amount recalled
- 1401 units
Where it was sold
Why it was recalled
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
This product could cause temporary or reversible health problems — stop using it.
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