The Recall Desk
HighFDA (Devices)·Z-2561-2019·Announced 2019-10-02

Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

Elekta Inc is recalling 49 Monaco RTP Systems because unintentional changes to electron density settings may cause incorrect dose calculations for radiation therapy 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 used for radiation therapy where incorrect dose calculations could lead to patient harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Elekta Inc is recalling 49 units of the Monaco RTP System, versions 5.50 and 5.51. This radiation treatment planning system is used to calculate dose for photon, electron, and carbon treatment plans for patients prescribed external beam radiation therapy. The affected units were distributed worldwide, including in the United States (WI, OH, NY, IN, IA, TX) and in Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, the Netherlands, Sweden, and the UK.

The recall was initiated because it is possible that forced electron density settings for some structures may be changed unintentionally. This defect can result in incorrect dose calculations within the treatment plans. The system is intended for use in radiation treatment planning, including contouring, image manipulation, simulation, image fusion, plan optimization, and quality assurance.

Healthcare facilities and users of the Monaco RTP System should contact Elekta Inc for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans
Manufacturer
Elekta Inc
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
49

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)

  • UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Elekta Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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