Reported Sep 10, 2014 · Terminated
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation…
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 · Atlanta, GA · 30346-1227
Is this the product you have?
- Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
- Lot codes and dates
- Versions 3.20.00 and higher
- Amount recalled
- 928 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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