The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2560-2019·Announced 2019-10-02

Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

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 3/5 (High).

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 a software defect could lead to incorrect dose calculations. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Elekta Inc is recalling 30 units of the Monaco RTP System, 5.40 Unity, a radiation treatment planning system. The system is used to make treatment plans for patients with prescriptions for external beam radiation therapy, calculating dose for photon, electron, and carbon treatment plans.

The recall was initiated because it is possible that the forced electron density settings will be changed for some structures unintentionally. This issue can result in incorrect dose calculation. 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, Netherlands, Sweden, and the UK.

Healthcare facilities should contact Elekta Inc for further instructions regarding the recall and potential remediation of the affected systems.

The recalled product

Product
Monaco RTP System, 5.40 Unity, 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…
Manufacturer
Elekta Inc
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
30

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)00858164002190(10) 5.40.00

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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