The Recall Desk
HighFDA (Devices)·Z-1233-2023·Announced 2023-03-15

Monaco RTP System software may calculate radiation therapy doses inaccurately

Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.

What this means for you

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 recall of a medical device used in cancer treatment where the software defect poses a risk of harm through inaccurate radiation dosing. No illnesses or injuries have been reported in the source text, and the hazard remains theoretical rather than manifested. Per the severity rubric, risk-of-harm products without reported injuries receive a score of 3 (High).

Plain-English summary

Elekta Inc. has recalled the Monaco RTP System (Radiation Therapy Planning System) software builds 5.11.00, 5.11.01, 5.11.02, and 5.11.03. This software is used to create radiation therapy treatment plans for cancer patients receiving external beam radiation therapy.

The recall addresses a software defect that may result in inaccurate radiation dose presentation. When a clinician adds anatomical contours to a treatment plan without using the "forced density outside" feature and then re-optimizes the plan, the system may display incorrect dose information. This could affect the accuracy of radiation therapy administration.

The Monaco RTP System has been distributed nationwide in the United States and internationally to approximately 80 countries including Canada, Australia, Europe, Asia, and other regions. Approximately 2,020 units are affected by this recall.

Healthcare providers using affected versions of the Monaco RTP System should independently verify radiation dose calculations displayed in treatment plans before administering therapy to patients. Elekta Inc. has released updated software to address this issue.

The recalled product

Product
Monaco RTP System. 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
2,020

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 Build: 5.11.00
  • 5.11.01
  • 5.11.02
  • 5.11.03
  • UDI Numbers: (01)00858164002169(10)5.11.00
  • (01)00858164002169(10)5.11.01
  • (01)00858164002169(10)5.11.02
  • (01)00858164002169(10)5.11.03

Distribution

Distributed nationwide across the United States.

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