Agency classClass IIOur severity:High FDA (Devices)·Z-2409-2019·Announced 2019-09-04

Elekta Monaco Radiation Treatment Planning System Software Recall

Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (radiation treatment planning) where incorrect data could lead to treatment errors, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Elekta, Inc. is recalling 49 units of the Monaco Radiation Treatment Planning System (RTP) System. The recall involves software builds 5.50.00 and 5.51.00. The affected units were distributed within the United States to Ohio and Indiana, as well as internationally to Germany, Greece, and Sweden.

The recall is due to a software defect where the system displays the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report. Additionally, the system is exporting incorrect Anatomy and Beam shift directions via DICOM. This error could impact the accuracy of radiation treatment planning.

Healthcare facilities that have purchased or received these specific software builds should contact Elekta, Inc. for further instructions on how to resolve the issue. Consumers are not directly affected by this recall, as the product is a professional medical device used in clinical settings.

The recalled product

Product: Monaco Radiation Treatment Planning System (RTP) System
Manufacturer: Elekta, Inc.
Category: Medical Device — Radiation Therapy Software
Hazard: software-error
incorrect-data
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 (3)

Software Build: 5.50.00 & 5.51.00
UDI GTIN: (01)00858164002244(10) 5.50.00
(01)00858164002268(10) 5.51.00

Distribution

Distributed in 2 states:

Same manufacturer · Elekta, Inc.

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