The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2276-2013·Announced 2013-10-02

Elekta Monaco Radiation Treatment Planning System Software Recall

Elekta is recalling Monaco RTP System software versions 3.10.00 and later because an upgrade script may overwrite treatment couch files with incorrect default values.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software defect regarding file overwriting without reporting any patient injuries, illnesses, or deaths. Per the rubric, this falls under moderate severity as a precautionary recall for a defect that has not resulted in reported harm.

Plain-English summary

Elekta, Inc. is recalling 45 units of the Monaco RTP System, a radiation treatment planning software system. The recall affects software versions 3.10.00 and later. The product was distributed nationwide, including in Alaska, California, Colorado, Connecticut, Florida, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and Puerto Rico.

The recall is due to a defect in the upgrade installation script. The script is designed to overwrite specific pouch files in the Treatment Couch Library with original default values. This action may result in the loss of customized treatment couch data or incorrect default settings being applied during the upgrade process.

Healthcare facilities using the affected software versions should contact Elekta, Inc. for instructions on how to resolve the issue. Users should verify their software version and consult with the manufacturer regarding the impact on their specific treatment planning workflows.

The recalled product

Product
Monaco RTP System Radiation treatment planning
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
45

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)

  • Versions 3.10.00 and later

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

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