Agency classClass IIOur severity:High FDA (Devices)·Z-2007-2012·Announced 2012-07-18

Elekta Monaco Software Recall for Incorrect Patient Shift Directions

Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

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 involves a risk-of-harm product (radiation therapy planning software) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Elekta, Inc. is recalling 38 units of Monaco software, used for the planning of radiation therapy. The recall covers software versions 3.10.00 through 3.20.00, inclusive. The software was distributed nationwide in the United States, including California, Connecticut, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Washington, and Wisconsin.

The recall was initiated because the software contains a defect that causes incorrect patient shift directions to be printed when the Setup reference dialog is generated. This error occurs specifically when the DICOM coordinates option is enabled for reports. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

Healthcare facilities that use Monaco software for radiation therapy planning should verify their software version and contact Elekta, Inc. for instructions on how to resolve the issue. Users should ensure that patient shift directions are manually verified against source data to prevent potential errors in treatment planning.

The recalled product

Product: Monaco Product Usage: Planning of radiation therapy
Manufacturer: Elekta, Inc.
Category: Medical Device — Radiation Therapy Planning Software
Hazard: software-defect
incorrect-data
Affected units: 38

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 (2)

Version 3.10.00 - 3.20.00
inclusive

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Elekta, Inc.

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