The Recall Desk
HighFDA (Devices)·Z-2581-2014·Announced 2014-09-10

Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery

Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that could lead to incorrect radiation delivery, a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Elekta, Inc. is recalling 928 units of the Monaco system, a software platform used to create treatment plans for external beam radiation therapy. The recall affects versions 3.20.00 and higher distributed worldwide, including the United States and numerous international locations.

The recall is due to a defect in the Composite Field Sequencing (CFS) feature. When exporting arc plans, such as VMAT, Dynamic Conformal, or 3D Static Arcs, using this feature, the DICOM exported plan may not match the approved treatment plan. This discrepancy could result in the incorrect delivery of radiation fields to patients.

Healthcare providers using the affected software should contact Elekta for instructions on how to address the issue and ensure patient safety. The source text does not report any specific illnesses or injuries resulting from this defect.

The recalled product

Product
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 d
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
928

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Versions 3.20.00 and higher

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

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