The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0668-2017·Announced 2016-12-07

Elekta Monaco TRP System Software Recall for CT Data Handling Error

Elekta, Inc. is recalling the Monaco TRP System software because it may incorrectly handle CT datasets with specific DICOM Z coordinates, potentially affecting treatment plan accuracy.

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, which typically corresponds to a Moderate severity score (2) in the absence of reported hospitalizations or injuries, as the defect involves software data handling rather than a direct physical hazard like fire or shock.

Plain-English summary

Elekta, Inc. is recalling the Monaco TRP System, a software system used to create treatment plans for patients prescribed external beam radiation therapy. The recall involves software builds 5.00 and higher. The issue arises when the CT dataset contains slices with DICOM Z coordinates of xx.x50mm, which are not handled correctly by the software.

The affected units were distributed worldwide, including in the United States (specifically AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, and Puerto Rico) and in numerous international locations. A total of 2,148 units are affected by this recall.

Healthcare providers and users of the Monaco TRP System should contact Elekta, Inc. for instructions on how to resolve the software defect. This recall is classified as Class II by the FDA, indicating that the use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
2,148

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)

  • Software Builds 5.00 and higher

Distribution

Distributed in 33 states:

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