The Recall Desk
HighFDA (Devices)·Z-0841-2013·Announced 2013-02-27

Elekta Monaco RTP System Recalled for Beam Angle Calculation Error

Elekta is recalling 13 Monaco RTP Systems because the beam is displayed at the gantry angle, but the dose is calculated at the rotation_start angle.

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 high-risk medical device (radiation treatment planning) where a calculation error could lead to incorrect dosing, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Elekta, Inc. is recalling 13 units of the Monaco RTP System, a radiation treatment planning software product. The recall is due to a software defect where the beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

The affected software versions are 3.20.00 and 3.20.01. The units were distributed nationwide, including in the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

Healthcare facilities should contact Elekta, Inc. for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
Monaco RTP System. Radiation treatment planning.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Treatment Planning Software
Hazard
Affected units
13

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 3.20.01

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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