The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0181-2016·Announced 2015-11-04

Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors

Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from incorrect radiation dosing.

Plain-English summary

Elekta, Inc. is recalling 154 units of Monaco Radiation Treatment Planning software, version 5.10.01. This software is used to create treatment plans for patients prescribed external beam radiation therapy. The recall was initiated because of a defect that caused unintended updates to Dose and MU (Monitor Unit) values and incorrect assignment of bolus.

The affected software was distributed in California, Indiana, Michigan, Missouri, Texas, and Wisconsin, as well as in Australia, Canada, Germany, Greece, India, the Netherlands, New Zealand, Turkey, and the United Kingdom. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare facilities using this software should contact Elekta, Inc. for instructions on how to address the defect and ensure patient safety. Patients who have received treatment using this software should consult their healthcare provider if they have concerns about their treatment plan.

The recalled product

Product
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
154

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)

  • Software Version 5.10.01

Distribution

Distributed in 6 states:

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