The Recall Desk
HighFDA (Devices)·Z-2406-2021·Announced 2021-09-08

Monaco RTP System software defect may cause incorrect radiation therapy dose calculations

Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.

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: This medical device recall involves a software defect in a radiation therapy planning system that could result in incorrect dose calculations. No reports of actual patient harm are mentioned in the recall notice, classifying this as a risk-of-harm product without reported injury, resulting in a High (3) severity per the established rubric.

Plain-English summary

Elekta Inc. is recalling specific software builds of the Monaco RTP System, a radiation therapy planning system used to calculate treatment doses for cancer patients. The affected software builds are 5.40.00, 5.40.01, 5.40.02, and 5.51.10.

A software defect has been identified in these builds. If a treatment couch (patient support) is removed while a treatment plan is loaded into the system, and the couch is then added back when the plan is unloaded, the system may calculate radiation doses with the couch improperly assigned to the radiation beams. This could result in inaccurate dose calculations.

The Monaco RTP System has been distributed in the United States in Iowa, New Jersey, New York, Pennsylvania, Tennessee, Texas, and Wisconsin. International distribution includes Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom.

Facilities using affected builds of the Monaco RTP System should contact Elekta Inc. for instructions on obtaining a software update that corrects this defect. Users should review affected treatment plans to ensure accurate dose calculations.

The recalled product

Product
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Manufacturer
Elekta Inc
Category
Medical Device — Radiation Therapy Planning System
Hazard

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 (3)

  • Software Builds: 5.40.00
  • 5.40.01
  • 5.40.02

Distribution

Distributed in 7 states:

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