The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2563-2021·Announced 2021-10-06

Radiation therapy planning software can save contours to wrong image set

Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected 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: This is an FDA Class II medical device recall affecting radiation therapy treatment planning software. Although no illnesses or injuries have been reported, the software defect presents a risk of harm by allowing treatment plan data to be saved incorrectly without proper dose-freezing controls.

Plain-English summary

Elekta Inc is recalling Elekta Monaco, a software system used to create treatment plans for patients undergoing external beam radiation therapy. The recall affects 214 units of the software worldwide, including installations in nine U.S. states (Pennsylvania, Michigan, Wisconsin, New York, Tennessee, New Jersey, Iowa, and Texas) and multiple international locations.

The software contains a defect where contour changes—outlines of anatomical structures used in treatment planning—can be inadvertently saved to an unintended image set. When this occurs, the contour edits do not cause the radiation dose to be frozen on the treatment plans associated with that image set.

Healthcare institutions using Elekta Monaco with the affected software builds (5.40.00, 5.40.01, 5.40.02, or 5.51.10) should contact Elekta Inc for corrective measures. The FDA has classified this as a Class II recall.

The recalled product

Product
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Manufacturer
Elekta Inc
Category
Medical Device — Radiation Therapy Planning Software
Hazard
Affected units
214

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 (8)

  • Software Builds: 5.40.00
  • 5.40.01
  • 5.40.02
  • 5.51.10
  • UDI GTIN: (01)00858164002190(10) 5.40.00
  • (01)00858164002190(10) 5.40.01
  • (01)00858164002190(10) 5.40.02
  • (01)00858164002268(10) 5.51.10

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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